Metformin
- Product NDC
- 68645-595
- 11-digit product format
- 686450595
- Labeler code
- 68645
- Product ID
- 68645-595_4cc275b9-2cfb-6f05-e063-6294a90a6e11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin ER 500 mg
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA209313
- Marketing category
- ANDA
- Marketing start
- 2022-03-10
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68645-595-59 | Metformin | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-595 | METFORMIN (METFORMIN ER 500 MG) TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 18 | Current NDC, Legacy NDC, 1 package rows | 20250502_d9e0816d-fd61-1ac2-e053-2995a90a4054.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68645-595-59 | 68645059559 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68645-595-59) | 2022-03-10 | 0000-00-00 | No | No | Current |