METFORMIN HYDROCHLORIDE
- Product NDC
- 68382-759
- 11-digit product format
- 683820759
- Labeler code
- 68382
- Product ID
- 68382-759_ded2d979-09e7-4e52-b69d-b362bf3c1698
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA203686
- Marketing category
- ANDA
- Marketing start
- 2014-12-09
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METFORMIN HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 850 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-759-01 | METFORMIN HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 15 |
| 68382-759-05 | METFORMIN HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 15 |
| 68382-759-10 | METFORMIN HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 15 |
| 68382-759-16 | METFORMIN HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 15 |
| 68382-759-30 | METFORMIN HYDROCHLORIDE | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 15 |
| 68382-759-77 | METFORMIN HYDROCHLORIDE | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| GLYCERYL BEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.] | 7 | |
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] | 2 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION] | 2 | |
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-759 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 14 | Current NDC, Legacy NDC, 6 package rows | 20231110_c82a10fa-1e8e-46b6-890a-737de3f34ee1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68382-759-01 | 68382075901 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-759-01) | | 2014-12-09 | 0000-00-00 | No | No | Current |
| 68382-759-05 | 68382075905 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-759-05) | | 2014-12-09 | 0000-00-00 | No | No | Current |
| 68382-759-10 | 68382075910 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-759-10) | | 2014-12-09 | 0000-00-00 | No | No | Current |
| 68382-759-16 | 68382075916 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-759-16) | | 2014-12-09 | 0000-00-00 | No | No | Current |
| 68382-759-30 | 68382075930 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68382-759-77 | 68382075977 | 100 BLISTER PACK in 1 CARTON (68382-759-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-759-30) | 100 blister pack | 2014-12-09 | 0000-00-00 | No | No | Current |