Metformin hydrochloride
- Product NDC
- 68645-583
- 11-digit product format
- 686450583
- Labeler code
- 68645
- Product ID
- 68645-583_4cc25d36-a09a-4f23-e063-6294a90a665d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2019-06-07
- 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 | 861004, 861007, 861010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68645-583-59 | Metformin hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-583 | METFORMIN HYDROCHLORIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 13 | Current NDC, Legacy NDC, 1 package rows | 20250418_b51da8d7-ab4a-4c40-97c9-88bd379366d1.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 |
|---|
| 68645-583-59 | 68645058359 | 60 TABLET in 1 BOTTLE (68645-583-59) | 60 tablet | 2019-06-07 | 0000-00-00 | No | No | Current |