METFORMIN HYDROCHLORIDE
- Product NDC
- 68788-8564
- 11-digit product format
- 687888564
- Labeler code
- 68788
- Product ID
- 68788-8564_d05d2f97-e42b-43f7-a89d-820224a6822e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA213320
- Marketing category
- ANDA
- Marketing start
- 2024-01-11
- Marketing end
- 2026-09-30
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METFORMIN HYDROCHLORIDE
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861007 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8564-1 | METFORMIN HYDROCHLORIDE | 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 |
|---|
| 68788-8564 | METFORMIN HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 1 package rows | 20240206_5073c482-952c-400c-afff-64380f133bc8.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 |
|---|
| 68788-8564-1 | 68788856401 | 100 TABLET in 1 BOTTLE (68788-8564-1) | 100 tablet | 2024-01-11 | 2026-09-30 | No | No | Historical |