Metformin Hydrochloride
- Product NDC
- 53746-220
- 11-digit product format
- 537460220
- Labeler code
- 53746
- Product ID
- 53746-220_87735a77-fc44-4fb2-b8f4-1dc44d13ad0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA077880
- Marketing category
- ANDA
- Marketing start
- 2012-12-17
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861004, 861007, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53746-220-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 13 |
| 53746-220-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 13 |
| 53746-220-10 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | METFORMIN HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] | 7 | |
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-220 | METFORMIN HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 13 | Current NDC, Legacy NDC, 3 package rows | 20240420_b090b18b-b53c-4c92-892f-d11551cfedc3.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 |
|---|
| 53746-220-01 | 53746022001 | 100 TABLET in 1 BOTTLE (53746-220-01) | 100 tablet | 2012-12-17 | 0000-00-00 | No | No | Current |
| 53746-220-05 | 53746022005 | 500 TABLET in 1 BOTTLE (53746-220-05) | 500 tablet | 2012-12-17 | 0000-00-00 | No | No | Current |
| 53746-220-10 | 53746022010 | 1000 TABLET in 1 BOTTLE (53746-220-10) | 1000 tablet | 2012-12-17 | 0000-00-00 | No | No | Current |