Metformin Hydrochloride
- Product NDC
- 67296-1701
- 11-digit product format
- 672961701
- Labeler code
- 67296
- Product ID
- 67296-1701_2c62e72c-7dec-d183-e063-6394a90a9d2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- RedPharm Drug, Inc.
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2019-11-01
- 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 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67296-1701-3 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 9 |
| 67296-1701-6 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-1701 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REDPHARM DRUG, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20210115_96b40564-d7d6-655b-e053-2a95a90a1f95.zip |
| 67296-1701 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [REDPHARM DRUG, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250124_fc61bafa-a506-14ae-e053-6394a90a9c7d.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 |
|---|
| 67296-1701-3 | 67296170103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (67296-1701-3) | 2019-11-01 | 0000-00-00 | No | No | Current |
| 67296-1701-6 | 67296170106 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (67296-1701-6) | 2019-11-01 | | No | No | Current |