OLMESARTAN MEDOXOMIL- olmesartan medoxomil tablet, film coated
Zydus Lifesciences Limited

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OLMESARTAN MEDOXOMIL TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1059-1

Olmesartan Medoxomil Tablets, 5 mg

Rx only

100 TABLETS

NDC 70771-1060-1

Olmesartan Medoxomil Tablets, 20 mg

Rx only

100 TABLETS

NDC 70771-1061-1

Olmesartan Medoxomil Tablets, 40 mg

Rx only

100 TABLETS

OLMESARTAN MEDOXOMIL
olmesartan medoxomil tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)	OLMESARTAN MEDOXOMIL	5 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1059-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
2	NDC:70771-1059-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
3	NDC:70771-1059-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
4	NDC:70771-1059-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
5	NDC:70771-1059-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
6	NDC:70771-1059-7	10 in 1 CARTON	04/24/2017	03/25/2025
6	NDC:70771-1059-2	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	ANDA205192	04/24/2017	04/29/2025

OLMESARTAN MEDOXOMIL
olmesartan medoxomil tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)	OLMESARTAN MEDOXOMIL	20 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1060-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
2	NDC:70771-1060-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
3	NDC:70771-1060-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
4	NDC:70771-1060-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
5	NDC:70771-1060-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
6	NDC:70771-1060-7	10 in 1 CARTON	04/24/2017	03/25/2025
6	NDC:70771-1060-2	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	ANDA205192	04/24/2017	04/29/2025

OLMESARTAN MEDOXOMIL
olmesartan medoxomil tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10)	OLMESARTAN MEDOXOMIL	40 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1061-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
2	NDC:70771-1061-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
3	NDC:70771-1061-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
4	NDC:70771-1061-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
5	NDC:70771-1061-0	1000 in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2017	03/25/2025
6	NDC:70771-1061-7	10 in 1 CARTON	04/24/2017	03/25/2025
6	NDC:70771-1061-2	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	ANDA205192	04/24/2017	04/29/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (863362789)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1059, 70771-1060, 70771-1061) , MANUFACTURE(70771-1059, 70771-1060, 70771-1061)

Revised: 4/2025

Document Id: 7e978ad5-aa3a-4a0c-bd5d-e177c317d69c

Set id: 18f90bd4-cca2-4e70-845a-7021b818307e

Version: 6

Effective Time: 20250429

Zydus Lifesciences Limited