Metformin Hydrochloride
- Product NDC
- 71709-112
- 11-digit product format
- 717090112
- Labeler code
- 71709
- Product ID
- 71709-112_63699815-ee85-645d-e053-2a91aa0a7c4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Metcure Pharmaceuticals, Inc.
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2017-11-14
- 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 |
|---|
| 71709-112-06 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 71709-112-07 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71709-112 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [METCURE PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20180228_5df6adc9-79fd-66ef-e053-2991aa0a75ce.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 |
|---|
| 71709-112-06 | 71709011206 | 500 TABLET, FILM COATED in 1 BOTTLE (71709-112-06) | 2017-11-14 | 0000-00-00 | No | No | Current |
| 71709-112-07 | 71709011207 | 1000 TABLET, FILM COATED in 1 BOTTLE (71709-112-07) | 2017-11-14 | 0000-00-00 | No | No | Current |