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![BUPROPION TABLET, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/78d34aad-9d4f-48c4-91eb-536e31c6b6c9/577eda07-fd4e-494e-a769-5338ba679892-03.jpg)
| NDC | 65841-780-05, 65841-780-06, 65841-780-10, 65841-780-16, 65841-836-05, 65841-836-06, 65841-836-10, 65841-836-16 |
| Set ID | 78d34aad-9d4f-48c4-91eb-536e31c6b6c9 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Aminoketone |
| Product Number | |
| Application Number | ANDA201567 |
- MEDICATION GUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BUPROPION
bupropion tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-780 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31) BUPROPION HYDROCHLORIDE 300 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID (UNII: 1CS02G8656) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) POVIDONE (UNII: FZ989GH94E) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) Product Characteristics Color YELLOW (CREAMY WHITE TO PALE YELLOW) Score no score Shape ROUND (ROUND) Size 9mm Flavor Imprint Code 354 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-780-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2014 2 NDC:65841-780-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2014 3 NDC:65841-780-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2014 4 NDC:65841-780-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201567 02/15/2014 BUPROPION
bupropion tablet, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-836 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPROPION HYDROCHLORIDE (UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31) BUPROPION HYDROCHLORIDE 150 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) METHACRYLIC ACID (UNII: 1CS02G8656) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) POVIDONE (UNII: FZ989GH94E) ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BUTYL ALCOHOL (UNII: 8PJ61P6TS3) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) Product Characteristics Color YELLOW (CREAMY WHITE TO PALE YELLOW) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code 353 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-836-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/02/2018 2 NDC:65841-836-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/02/2018 3 NDC:65841-836-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/02/2018 4 NDC:65841-836-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 08/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201567 08/02/2018 Labeler - Cadila Healthcare Limited (918596198) Registrant - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(65841-780, 65841-836) , MANUFACTURE(65841-780, 65841-836)
