Metformin Hydrochloride
- Product NDC
- 42291-498
- 11-digit product format
- 422910498
- Labeler code
- 42291
- Product ID
- 42291-498_51b59b71-5da1-dbb2-e063-6394a90ab15f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA078596
- Marketing category
- ANDA
- Marketing start
- 2022-03-31
- Marketing end
- 2026-05-31
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-498-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 4 |
| 42291-498-18 | Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 4 |
| 42291-498-50 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 4 |
| 42291-498-90 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-498 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVKARE] | 2 | Current NDC, Legacy NDC, 4 package rows | 20230426_db893bbe-95af-bbec-e053-2a95a90ae0e9.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 |
|---|
| 42291-498-01 | 42291049801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-498-01) | 2022-03-31 | 2026-05-31 | No | No | Current |
| 42291-498-18 | 42291049818 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-498-18) | 2022-03-31 | 2026-05-31 | No | No | Current |
| 42291-498-50 | 42291049850 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-498-50) | 2022-03-31 | 2026-05-31 | No | No | Current |
| 42291-498-90 | 42291049890 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-498-90) | 2023-04-25 | 2026-05-31 | No | No | Historical |