METFORMIN HYDROCHLORIDE
- Product NDC
- 42806-633
- 11-digit product format
- 428060633
- Labeler code
- 42806
- Product ID
- 42806-633_1b4daf1d-a7a9-8fd1-e063-6294a90a817e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA211052
- Marketing category
- ANDA
- Marketing start
- 2020-07-08
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METFORMIN HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975, 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-633-01 | METFORMIN HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 6 |
| 42806-633-05 | METFORMIN HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 6 |
| 42806-633-10 | METFORMIN HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-633 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [EPIC PHARMA, LLC] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240621_a9e7608f-540c-d90c-e053-2a95a90a4f98.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 |
|---|
| 42806-633-01 | 42806063301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-633-01) | 2020-07-08 | 0000-00-00 | No | No | Current |
| 42806-633-05 | 42806063305 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-633-05) | 2020-07-08 | 0000-00-00 | No | No | Current |
| 42806-633-10 | 42806063310 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-633-10) | 2020-07-08 | 0000-00-00 | No | No | Current |