Metformin Hydrochloride
- Product NDC
- 11788-038
- 11-digit product format
- 117880038
- Labeler code
- 11788
- Product ID
- 11788-038_5ad15c75-5a99-4fa0-96f8-21e75064eff3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride Extended-Release Tablets
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AiPing Pharmaceutical, Inc.
- Application
- ANDA209993
- Marketing category
- ANDA
- Marketing start
- 2025-12-15
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 1807894, 1807917 |
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 |
|---|
| 11788-038-60 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11788-038 | METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [AIPING PHARMACEUTICAL, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20220116_96c8a89d-99db-24b1-e053-2a95a90ac2b8.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 |
|---|
| 11788-038-60 | 11788003860 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (11788-038-60) | 2025-12-15 | 0000-00-00 | No | No | Current |