Metformin Hydrochloride
- Product NDC
- 69238-2125
- 11-digit product format
- 692382125
- Labeler code
- 69238
- Product ID
- 69238-2125_7e91bdf3-12b0-4816-b607-6c42b9d99df7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA078596
- Marketing category
- ANDA
- Marketing start
- 2009-12-02
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975, 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69238-2125-1 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 5 |
| 69238-2125-3 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 5 |
| 69238-2125-5 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 5 |
| 69238-2125-7 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 5 |
| 69238-2125-9 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-2125 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] | 4 | Current NDC, Legacy NDC, 5 package rows | 20231128_dc65065b-cba0-46d7-8fb5-3368f3210b4d.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 |
|---|
| 69238-2125-1 | 69238212501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-1) | 2009-12-02 | 0000-00-00 | No | No | Current |
| 69238-2125-3 | 69238212503 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-3) | 2009-12-02 | 0000-00-00 | No | No | Current |
| 69238-2125-5 | 69238212505 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-5) | 2009-12-02 | 0000-00-00 | No | No | Current |
| 69238-2125-7 | 69238212507 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-7) | 2009-12-02 | 0000-00-00 | No | No | Current |
| 69238-2125-9 | 69238212509 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2125-9) | 2009-12-02 | 0000-00-00 | No | No | Current |