Metformin hydrochloride
- Product NDC
- 71610-867
- 11-digit product format
- 716100867
- Labeler code
- 71610
- Product ID
- 71610-867_2bc26279-774d-c799-e063-6394a90aae86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA207427
- Marketing category
- ANDA
- Marketing start
- 2024-06-11
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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
- Brand name suffix
- ER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-867-53 | Metformin hydrochlorideER | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 2 |
| 71610-867-60 | Metformin hydrochlorideER | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | | 2 |
| 71610-867-70 | Metformin hydrochlorideER | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | | 2 |
| 71610-867-80 | Metformin hydrochlorideER | 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 |
|---|
| 71610-867 | METFORMIN HYDROCHLORIDE ER (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] | 2 | Current NDC, 4 package rows | 20250117_27d6fdbc-27a8-c599-e063-6394a90a2233.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-867-53 | 71610086753 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-53) | 2024-11-25 | No | No | Historical |
| 71610-867-60 | 71610086760 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-60) | 2024-11-25 | No | No | Historical |
| 71610-867-70 | 71610086770 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-70) | 2024-11-25 | No | No | Historical |
| 71610-867-80 | 71610086780 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-80) | 2025-01-13 | No | No | Historical |