Metformin Hydrochloride
- Product NDC
- 50268-551
- 11-digit product format
- 502680551
- Labeler code
- 50268
- Product ID
- 50268-551_47e75091-dca6-2523-e063-6394a90a54ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2022-05-02
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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 | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-551-11 | Metformin Hydrochloride | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 6 |
| 50268-551-15 | Metformin Hydrochloride | 50 in 1 BOX | TABLET, EXTENDED RELEASE | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-551 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVPAK] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240921_de09f7a1-1e9f-60f4-e053-2a95a90a93d8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-551-11 | 50268055111 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-551-15 | 50268055115 | 50 BLISTER PACK in 1 BOX (50268-551-15) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-551-11) | 50 blister pack | 2022-05-02 | 0000-00-00 | No | No | Current |