Metformin Hydrochloride
- Product NDC
- 42806-314
- 11-digit product format
- 428060314
- Labeler code
- 42806
- Product ID
- 42806-314_b7b6b188-b148-4c9f-8e7b-1fad061209ea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2017-03-13
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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 | 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 |
|---|
| 42806-314-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 42806-314-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 42806-314-10 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-314 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] | 3 | Current NDC, Legacy NDC, 3 package rows | 20191106_8c1848f9-c113-4552-b6ef-715e72630ad9.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 |
|---|
| 42806-314-01 | 42806031401 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-314-01) | 2017-03-13 | 0000-00-00 | No | No | Current |
| 42806-314-05 | 42806031405 | 500 TABLET, FILM COATED in 1 BOTTLE (42806-314-05) | 2017-03-13 | 0000-00-00 | No | No | Current |
| 42806-314-10 | 42806031410 | 1000 TABLET, FILM COATED in 1 BOTTLE (42806-314-10) | 2017-03-13 | 0000-00-00 | No | No | Current |