Metformin Hydrochloride
- Product NDC
- 71610-578
- 11-digit product format
- 716100578
- Labeler code
- 71610
- Product ID
- 71610-578_ae39b6bc-4b1a-4db9-b5a1-7195832a1cec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA206145
- Marketing category
- ANDA
- Marketing start
- 2018-10-27
- 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 Hydrochloride
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-578-60 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 1 |
| 71610-578-70 | Metformin Hydrochloride | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | | 1 |
| 71610-578-80 | Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 1 |
| 71610-578-94 | Metformin Hydrochloride | 360 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 360 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-578 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 4 package rows | 20210803_1e298db3-439e-4e91-8f9e-01c3cdc4d552.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 |
|---|
| 71610-578-60 | 71610057860 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-60) | 2021-07-01 | 0000-00-00 | No | No | Current |
| 71610-578-70 | 71610057870 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-70) | 2021-07-01 | 0000-00-00 | No | No | Current |
| 71610-578-80 | 71610057880 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-80) | 2021-07-01 | 0000-00-00 | No | No | Current |
| 71610-578-94 | 71610057894 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-94) | 2021-07-01 | 0000-00-00 | No | No | Current |