Metformin
- Product NDC
- 70010-492
- 11-digit product format
- 700100492
- Labeler code
- 70010
- Product ID
- 70010-492_451bc376-d523-ee84-e063-6394a90a4743
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin ER 750 mg
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- ANDA209313
- Marketing category
- ANDA
- Marketing start
- 2018-07-31
- 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
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70010-492-01 | Metformin | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 19 |
| 70010-492-05 | Metformin | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 19 |
| 70010-492-20 | Metformin | 3500 in 1 POUCH | TABLET, EXTENDED RELEASE | 3500 | | 19 |
| 70010-492-21 | Metformin | 17500 in 1 CARTON | TABLET, EXTENDED RELEASE | 17500 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70010-492 | METFORMIN (METFORMIN ER 500 MG) TABLET, EXTENDED RELEASE METFORMIN (METFORMIN ER 750 MG) TABLET, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.] | 18 | Current NDC, Legacy NDC, 4 package rows | 20240704_6d6ee6f8-9650-ff4f-e053-2991aa0acf19.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 |
|---|
| 70010-492-01 | 70010049201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-492-01) | | 2018-07-31 | 0000-00-00 | No | No | Current |
| 70010-492-05 | 70010049205 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-492-05) | | 2018-07-31 | 0000-00-00 | No | No | Current |
| 70010-492-09 | 70010049209 | 90 TABLET in 1 BOTTLE (70010-492-09) | 90 tablet | 2020-04-16 | 0000-00-00 | No | No | Current |
| 70010-492-20 | 70010049220 | 3500 TABLET, EXTENDED RELEASE in 1 POUCH (70010-492-20) | | 2019-06-14 | 0000-00-00 | No | No | Current |
| 70010-492-21 | 70010049221 | 17500 TABLET, EXTENDED RELEASE in 1 CARTON (70010-492-21) | | 2019-06-14 | 0000-00-00 | No | No | Current |