METFORMIN HYDROCHLORIDE
- Product NDC
- 68462-520
- 11-digit product format
- 684620520
- Labeler code
- 68462
- Product ID
- 68462-520_75378e1b-a55d-48ee-9a0a-cd82d2fb78a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Application
- ANDA212969
- Marketing category
- ANDA
- Marketing start
- 2019-11-25
- 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 HYDROCHLORIDE
- 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 | 1807888, 1807915 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-520-01 | METFORMIN HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 4 |
| 68462-520-05 | METFORMIN HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 4 |
| 68462-520-10 | METFORMIN HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-520 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLENMARK PHARMACEUTICALS INC., USA] | 3 | Current NDC, Legacy NDC, 3 package rows | 20240104_0ef9de1a-b786-4b6c-a250-3f5ac532b16a.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 |
|---|
| 68462-520-01 | 68462052001 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-520-01) | 2019-11-25 | 0000-00-00 | No | No | Current |
| 68462-520-05 | 68462052005 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-520-05) | 2019-11-25 | 0000-00-00 | No | No | Current |
| 68462-520-10 | 68462052010 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-520-10) | 2019-11-25 | 0000-00-00 | No | No | Current |