Metformin ER 750 mg
- Product NDC
- 82009-118
- 11-digit product format
- 820090118
- Labeler code
- 82009
- Product ID
- 82009-118_451e9a75-128c-6b1d-e063-6394a90aa5d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin ER 750 mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA209313
- Marketing category
- ANDA
- Marketing start
- 2023-07-25
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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 ER 750 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 750 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 |
|---|
| 82009-118-01 | Metformin ER 750 mg | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-118 | METFORMIN ER 500 MG TABLET METFORMIN ER 750 MG TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC] | 1 | Current NDC, 1 package rows | 20230725_ff196435-14f4-8b9d-e053-6294a90a4ee8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-118-01 | 82009011801 | 100 TABLET in 1 BOTTLE (82009-118-01) | 100 tablet | 2023-07-25 | No | No | Current |