Metformin Hydrochloride
- Product NDC
- 65162-178
- 11-digit product format
- 651620178
- Labeler code
- 65162
- Product ID
- 65162-178_984302ad-793e-4f35-92da-e5e7f92154f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA078596
- Marketing category
- ANDA
- Marketing start
- 2009-12-02
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975, 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-178-03 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 8 |
| 65162-178-09 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 8 |
| 65162-178-10 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 8 |
| 65162-178-11 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 8 |
| 65162-178-50 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 8 |
| 65162-178-89 | Metformin Hydrochloride | 10000 in 1 DRUM | TABLET, EXTENDED RELEASE | 10000 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-178 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC] | 8 | Current NDC, Legacy NDC, 6 package rows | 20241031_c01a79e0-f2b7-4d99-857e-bda7f24fe319.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-178-03 | 65162017803 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-03) | 2009-12-02 | 0000-00-00 | No | No | Current |
| 65162-178-09 | 65162017809 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-09) | 2009-12-02 | 0000-00-00 | No | No | Current |
| 65162-178-10 | 65162017810 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-10) | 2009-12-02 | 0000-00-00 | No | No | Current |
| 65162-178-11 | 65162017811 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-11) | 2009-12-02 | 0000-00-00 | No | No | Current |
| 65162-178-50 | 65162017850 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-50) | 2009-12-02 | 0000-00-00 | No | No | Current |
| 65162-178-89 | 65162017889 | 10000 TABLET, EXTENDED RELEASE in 1 DRUM (65162-178-89) | 2009-12-02 | 0000-00-00 | No | No | Current |