METFORMIN HYDROCHLORIDE
- Product NDC
- 69315-410
- 11-digit product format
- 693150410
- Labeler code
- 69315
- Product ID
- 69315-410_5030d813-bbf7-d62e-e063-6394a90ab078
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2025-05-01
- 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
- Brand name suffix
- ER
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-410-01 | METFORMIN HYDROCHLORIDEER | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 4 |
| 69315-410-05 | METFORMIN HYDROCHLORIDEER | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-410 | METFORMIN HYDROCHLORIDE ER (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [LEADING PHARMA, LLC] | 2 | Current NDC, 2 package rows | 20250501_3dca884d-ec44-496f-9eeb-31fd8fa3f574.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69315-410-01 | 69315041001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-01) | 2025-05-01 | No | No | Historical |
| 69315-410-05 | 69315041005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-05) | 2025-05-01 | No | No | Historical |