Metformin
- Product NDC
- 71610-613
- 11-digit product format
- 716100613
- Labeler code
- 71610
- Product ID
- 71610-613_1a8b9788-48c5-15f5-e063-6394a90a2e11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin ER 500 mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA209313
- Marketing category
- ANDA
- Marketing start
- 2018-07-31
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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
- Listing expiration
- 2026-12-31
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#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-613 | METFORMIN (METFORMIN ER 500 MG) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 4 | Current NDC, Legacy NDC, 6 package rows | 20240612_5c10eaa2-d6ba-446a-8f16-f5a8ca7223d7.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 |
|---|
| 71610-613-30 | 71610061330 | 30 TABLET in 1 BOTTLE (71610-613-30) | 30 tablet | 2024-05-02 | | No | No | Historical |
| 71610-613-53 | 71610061353 | 60 TABLET in 1 BOTTLE (71610-613-53) | 60 tablet | 2024-06-04 | | No | No | Historical |
| 71610-613-60 | 71610061360 | 90 TABLET in 1 BOTTLE (71610-613-60) | 90 tablet | 2021-11-02 | 0000-00-00 | No | No | Current |
| 71610-613-70 | 71610061370 | 120 TABLET in 1 BOTTLE (71610-613-70) | 120 tablet | 2024-03-01 | | No | No | Historical |
| 71610-613-80 | 71610061380 | 180 TABLET in 1 BOTTLE (71610-613-80) | 180 tablet | 2021-11-02 | 0000-00-00 | No | No | Current |
| 71610-613-94 | 71610061394 | 360 TABLET in 1 BOTTLE (71610-613-94) | 360 tablet | 2021-11-02 | 0000-00-00 | No | No | Current |