Metformin hydrochloride
- Product NDC
- 42291-824
- 11-digit product format
- 422910824
- Labeler code
- 42291
- Product ID
- 42291-824_42c9e096-bccc-ad6e-e063-6294a90a4e5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA207427
- Marketing category
- ANDA
- Marketing start
- 2024-06-11
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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
- Brand name suffix
- ER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 750 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 |
|---|
| 42291-824-10 | Metformin hydrochlorideER | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 3 |
| 42291-824-50 | Metformin hydrochlorideER | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 3 |
| 42291-824-90 | Metformin hydrochlorideER | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-824 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE METFORMIN HYDROCHLORIDE ER (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AVKARE] | 1 | Current NDC, 3 package rows | 20240613_1aa40000-877f-8ea4-e063-6394a90a0e31.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-824-10 | 42291082410 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-824-10) | 2025-11-03 | No | No | Current |
| 42291-824-50 | 42291082450 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-824-50) | 2024-06-11 | No | No | Current |
| 42291-824-90 | 42291082490 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-824-90) | 2024-06-11 | No | No | Current |