Metformin Hydrochloride
- Product NDC
- 71610-920
- 11-digit product format
- 716100920
- Labeler code
- 71610
- Product ID
- 71610-920_390c5ade-f983-c789-e063-6294a90a6d9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077095
- Marketing category
- ANDA
- Marketing start
- 2005-01-14
- 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
openFDA Listing Details
- Product ID
- 71610-920_390c5ade-f983-c789-e063-6294a90a6d9f
- SPL ID
- 390c5ade-f983-c789-e063-6294a90a6d9f
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Metformin Hydrochloride
- Generic name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2005-01-14
- Marketing category
- ANDA
- Application number
- ANDA077095
- Pharmacologic classes
- Biguanide [EPC]; Biguanides [CS]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861007 |
| Spl Set Id | 390c3bdf-bfaf-203e-e063-6394a90a7d20 |
| Manufacturer Name | Aphena Pharma Solutions - Tennessee, LLC |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71610-920-53 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-920-53) | 2025-07-01 | No |
| 71610-920-60 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-920-60) | 2025-07-01 | No |
| 71610-920-80 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-920-80) | 2025-07-01 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 786Z46389E | METFORMIN HYDROCHLORIDE | 1115-70-4 | METFORMIN HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-920-53 | 71610092053 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-920-53) | 2025-07-01 | No | No | Historical |
| 71610-920-60 | 71610092060 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-920-60) | 2025-07-01 | No | No | Historical |
| 71610-920-80 | 71610092080 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-920-80) | 2025-07-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Metformin Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | 2025-07-03 | HUMAN PRESCRIPTION DRUG LABEL | 1 |