Metformin Hydrochloride
- Product NDC
- 42571-334
- 11-digit product format
- 425710334
- Labeler code
- 42571
- Product ID
- 42571-334_46836128-22ce-1c77-e063-6294a90a9768
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Micro Labs Limited
- Application
- ANDA212448
- Marketing category
- ANDA
- Marketing start
- 2023-03-01
- 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 | 1807888, 1807915 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42571-334-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 4 |
| 42571-334-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 4 |
| 42571-334-60 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 4 |
| 42571-334-90 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42571-334 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MICRO LABS LIMITED] | 2 | Current NDC, 4 package rows | 20250515_cc070735-5e8d-4bb3-9caa-e84d29bb8943.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42571-334-01 | 42571033401 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-334-01) | 2023-03-01 | No | No | Current |
| 42571-334-05 | 42571033405 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-334-05) | 2023-03-01 | No | No | Current |
| 42571-334-60 | 42571033460 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-334-60) | 2023-03-01 | No | No | Current |
| 42571-334-90 | 42571033490 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-334-90) | 2023-03-01 | No | No | Current |