DailyMed - AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

NDC Code(s): 70771-1186-0, 70771-1186-1, 70771-1186-3, 70771-1186-5, view more
70771-1186-9, 70771-1187-0, 70771-1187-1, 70771-1187-2, 70771-1187-3, 70771-1187-4, 70771-1187-5, 70771-1187-9, 70771-1188-0, 70771-1188-1, 70771-1188-2, 70771-1188-3, 70771-1188-4, 70771-1188-5, 70771-1188-9, 70771-1189-0, 70771-1189-1, 70771-1189-2, 70771-1189-3, 70771-1189-4, 70771-1189-5, 70771-1189-9
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 13, 2022

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SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1186-3

Amlodipine and olmesartan medoxomil tablets, 5/20 mg

Rx only

30 tablets

NDC 70771-1187-3

Amlodipine and olmesartan medoxomil tablets, 10/20 mg

Rx only

30 tablets

NDC 70771-1188-3

Amlodipine and olmesartan medoxomil tablets, 5/40 mg

Rx only

30 tablets

NDC 70771-1189-3

Amlodipine and olmesartan medoxomil tablets, 10/40 mg

Rx only

30 tablets

INGREDIENTS AND APPEARANCE

AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine and olmesartan medoxomil tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1186
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	5 mg
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)	OLMESARTAN MEDOXOMIL	20 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE (WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	927
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1186-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
2	NDC:70771-1186-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
3	NDC:70771-1186-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
4	NDC:70771-1186-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
5	NDC:70771-1186-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207771	01/04/2018

AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine and olmesartan medoxomil tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1187
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10 mg
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)	OLMESARTAN MEDOXOMIL	20 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (ORANGE)	Score	no score
Shape	ROUND (ROUND)	Size	7mm
Flavor		Imprint Code	928
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1187-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
2	NDC:70771-1187-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
3	NDC:70771-1187-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
4	NDC:70771-1187-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
5	NDC:70771-1187-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
6	NDC:70771-1187-4	10 in 1 CARTON	01/04/2018
6	NDC:70771-1187-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207771	01/04/2018

AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine and olmesartan medoxomil tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1188
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	5 mg
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)	OLMESARTAN MEDOXOMIL	40 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	YELLOW (PALE YELLOW)	Score	no score
Shape	ROUND (ROUND)	Size	9mm
Flavor		Imprint Code	929
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1188-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
2	NDC:70771-1188-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
3	NDC:70771-1188-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
4	NDC:70771-1188-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
5	NDC:70771-1188-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
6	NDC:70771-1188-4	10 in 1 CARTON	01/04/2018
6	NDC:70771-1188-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207771	01/04/2018

AMLODIPINE AND OLMESARTAN MEDOXOMIL
amlodipine and olmesartan medoxomil tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1189
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)	AMLODIPINE	10 mg
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)	OLMESARTAN MEDOXOMIL	40 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE (ORANGE)	Score	no score
Shape	ROUND (ROUND)	Size	9mm
Flavor		Imprint Code	930
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1189-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
2	NDC:70771-1189-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
3	NDC:70771-1189-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
4	NDC:70771-1189-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
5	NDC:70771-1189-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2018
6	NDC:70771-1189-4	10 in 1 CARTON	01/04/2018
6	NDC:70771-1189-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA207771	01/04/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1186, 70771-1187, 70771-1188, 70771-1189) , MANUFACTURE(70771-1186, 70771-1187, 70771-1188, 70771-1189)

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Published Date (What is this?)	Version	Files
Oct 14, 2022	4 (current)	download
Aug 17, 2020	3	download
Dec 6, 2019	2	download
Jan 4, 2018	1	download

	RxCUI	RxNorm NAME	RxTTY
1	730861	amLODIPine 10 MG / olmesartan medoxomil 20 MG Oral Tablet	PSN
2	730861	amlodipine 10 MG / olmesartan medoxomil 20 MG Oral Tablet	SCD
3	730861	amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 20 MG Oral Tablet	SY
4	730866	amLODIPine 10 MG / olmesartan medoxomil 40 MG Oral Tablet	PSN
5	730866	amlodipine 10 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD
6	730866	amlodipine 10 MG (as amlodipine besylate 13.9 MG) / olmesartan medoxomil 40 MG Oral Tablet	SY
7	730869	amLODIPine 5 MG / olmesartan medoxomil 20 MG Oral Tablet	PSN
8	730869	amlodipine 5 MG / olmesartan medoxomil 20 MG Oral Tablet	SCD
9	730869	amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 20 MG Oral Tablet	SY
10	730872	amLODIPine 5 MG / olmesartan medoxomil 40 MG Oral Tablet	PSN
11	730872	amlodipine 5 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD
12	730872	amlodipine 5 MG (as amlodipine besylate 6.9 MG) / olmesartan medoxomil 40 MG Oral Tablet	SY

Label: AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

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	NDC
1	70771-1186-0
2	70771-1186-1
3	70771-1186-3
4	70771-1186-5
5	70771-1186-9
6	70771-1187-0
7	70771-1187-1
8	70771-1187-2
9	70771-1187-3
10	70771-1187-4
11	70771-1187-5
12	70771-1187-9
13	70771-1188-0
14	70771-1188-1
15	70771-1188-2
16	70771-1188-3
17	70771-1188-4
18	70771-1188-5
19	70771-1188-9
20	70771-1189-0
21	70771-1189-1
22	70771-1189-2
23	70771-1189-3
24	70771-1189-4
25	70771-1189-5
26	70771-1189-9

Label: AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

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AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

Number of versions: 4

AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

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AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.