METFORMIN HYDROCHLORIDE
- Product NDC
- 71610-447
- 11-digit product format
- 716100447
- Labeler code
- 71610
- Product ID
- 71610-447_f2b2e161-6f49-4a65-970e-017b5c4dcd74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077336
- Marketing category
- ANDA
- Marketing start
- 2006-02-09
- 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 |
|---|
| 71610-447-30 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 2 |
| 71610-447-53 | METFORMIN HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 2 |
| 71610-447-60 | METFORMIN HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 2 |
| 71610-447-70 | METFORMIN HYDROCHLORIDE | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | | 2 |
| 71610-447-80 | METFORMIN HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 2 |
| 71610-447-94 | METFORMIN HYDROCHLORIDE | 360 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 360 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-447 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC, 6 package rows | 20210428_439bb230-94d8-4522-ad79-5cce5fad965b.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 |
|---|
| 71610-447-30 | 71610044730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-30) | 2020-07-24 | 0000-00-00 | No | No | Current |
| 71610-447-53 | 71610044753 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-53) | 2020-07-24 | 0000-00-00 | No | No | Current |
| 71610-447-60 | 71610044760 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-60) | 2020-07-24 | 0000-00-00 | No | No | Current |
| 71610-447-70 | 71610044770 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-70) | 2020-07-24 | 0000-00-00 | No | No | Current |
| 71610-447-80 | 71610044780 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-80) | 2020-07-24 | 0000-00-00 | No | No | Current |
| 71610-447-94 | 71610044794 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-447-94) | 2021-03-11 | 0000-00-00 | No | No | Current |