Metformin Hydrochloride
- Product NDC
- 71610-533
- 11-digit product format
- 716100533
- Labeler code
- 71610
- Product ID
- 71610-533_61eefdc5-924c-4798-a8fd-ed8155dd85c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2008-04-17
- 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 |
|---|
| 71610-533-30 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 2 |
| 71610-533-53 | Metformin Hydrochloride | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 2 |
| 71610-533-60 | Metformin Hydrochloride | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 2 |
| 71610-533-70 | Metformin Hydrochloride | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | | 2 |
| 71610-533-80 | Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-533 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 5 package rows | 20210703_4d89a4ab-6cdd-4c39-92f9-a137fa27a070.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 |
|---|
| 71610-533-30 | 71610053330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-30) | 2021-04-15 | 0000-00-00 | No | No | Current |
| 71610-533-53 | 71610053353 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-53) | 2021-03-09 | 0000-00-00 | No | No | Current |
| 71610-533-60 | 71610053360 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-60) | 2021-04-15 | 0000-00-00 | No | No | Current |
| 71610-533-70 | 71610053370 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-70) | 2021-05-18 | 0000-00-00 | No | No | Current |
| 71610-533-80 | 71610053380 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-533-80) | 2021-05-18 | 0000-00-00 | No | No | Current |