Metformin Hydrochloride
- Product NDC
- 68788-8756
- 11-digit product format
- 687888756
- Labeler code
- 68788
- Product ID
- 68788-8756_1bb1a8f7-db48-4add-9c43-c87a272c09f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA209882
- Marketing category
- ANDA
- Marketing start
- 2024-10-14
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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 | 850 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8756-1 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 68788-8756-3 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 68788-8756-6 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 68788-8756-8 | Metformin Hydrochloride | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 2 |
| 68788-8756-9 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8756 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 5 package rows | 20241016_ca71c133-6c38-4b9e-80af-1949634157f4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8756-1 | 68788875601 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8756-1) | 2024-10-14 | No | No | Current |
| 68788-8756-3 | 68788875603 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8756-3) | 2024-10-14 | No | No | Current |
| 68788-8756-6 | 68788875606 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8756-6) | 2024-10-14 | No | No | Current |
| 68788-8756-8 | 68788875608 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8756-8) | 2024-10-14 | No | No | Current |
| 68788-8756-9 | 68788875609 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8756-9) | 2024-10-14 | No | No | Current |