Label: MEMANTINE HYDROCHLORIDE capsule, extended release
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NDC Code(s):
70771-1321-2,
70771-1321-3,
70771-1321-4,
70771-1321-9, view more70771-1322-2, 70771-1322-3, 70771-1322-4, 70771-1322-9, 70771-1323-2, 70771-1323-3, 70771-1323-4, 70771-1323-9, 70771-1324-2, 70771-1324-3, 70771-1324-4, 70771-1324-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 18, 2022
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- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Memantine Hydrochloride Extended-release Capsules, 7 mg
NDC 70771-1321-3
30 Counts
Memantine Hydrochloride Extended-release Capsules, 14 mg
70771-1322-3
30 Counts
Memantine Hydrochloride Extended-release Capsules, 21 mg
NDC 70771-1323-3
30 Counts
Memantine Hydrochloride Extended-release Capsules, 28 mg
NDC 70771-1324-3
30 Counts
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INGREDIENTS AND APPEARANCE
MEMANTINE HYDROCHLORIDE
memantine hydrochloride capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1321 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE 7 mg Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X) ALCOHOL (UNII: 3K9958V90M) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C) GELATIN (UNII: 2G86QN327L) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ISOPROPYL ALCOHOL (UNII: ND2M416302) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (WHITE) , WHITE (WHITE) Score no score Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code 546 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1321-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2018 2 NDC:70771-1321-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2018 3 NDC:70771-1321-4 10 in 1 CARTON 04/08/2018 3 NDC:70771-1321-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203293 04/08/2018 MEMANTINE HYDROCHLORIDE
memantine hydrochloride capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1322 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE 14 mg Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X) ALCOHOL (UNII: 3K9958V90M) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GELATIN (UNII: 2G86QN327L) HYPROMELLOSES (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color BLUE (LIGHT-BLUE) , GREEN (GREEN) Score no score Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code 547 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1322-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2018 2 NDC:70771-1322-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2018 3 NDC:70771-1322-4 10 in 1 CARTON 04/08/2018 3 NDC:70771-1322-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203293 04/08/2018 MEMANTINE HYDROCHLORIDE
memantine hydrochloride capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1323 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE 21 mg Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X) ALCOHOL (UNII: 3K9958V90M) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GELATIN (UNII: 2G86QN327L) HYPROMELLOSES (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE (WHITE) , GREEN (GREEN) Score no score Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code 548 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1323-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2018 2 NDC:70771-1323-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2018 3 NDC:70771-1323-4 10 in 1 CARTON 04/08/2018 3 NDC:70771-1323-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203293 04/08/2018 MEMANTINE HYDROCHLORIDE
memantine hydrochloride capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1324 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEMANTINE HYDROCHLORIDE (UNII: JY0WD0UA60) (MEMANTINE - UNII:W8O17SJF3T) MEMANTINE HYDROCHLORIDE 28 mg Inactive Ingredients Ingredient Name Strength AMMONIA (UNII: 5138Q19F1X) ALCOHOL (UNII: 3K9958V90M) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) ETHYLCELLULOSE (7 MPA.S) (UNII: H3UP11403C) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) GELATIN (UNII: 2G86QN327L) HYPROMELLOSES (UNII: 3NXW29V3WO) ISOPROPYL ALCOHOL (UNII: ND2M416302) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color GREEN (LIGHT-GREEN) , GREEN (LIGHT-GREEN) Score no score Shape CAPSULE (CAPSULE) Size 16mm Flavor Imprint Code 549 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1324-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2018 2 NDC:70771-1324-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/08/2018 3 NDC:70771-1324-4 10 in 1 CARTON 04/08/2018 3 NDC:70771-1324-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203293 04/08/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1321, 70771-1322, 70771-1323, 70771-1324) , MANUFACTURE(70771-1321, 70771-1322, 70771-1323, 70771-1324)