METFORMIN HYDROCHLORIDE
- Product NDC
- 72789-551
- 11-digit product format
- 727890551
- Labeler code
- 72789
- Product ID
- 72789-551_4cea555b-4105-0f82-e063-6394a90a90a9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA213320
- Marketing category
- ANDA
- Marketing start
- 2025-08-25
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METFORMIN HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861004 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-551-30 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 3 |
| 72789-551-42 | METFORMIN HYDROCHLORIDE | 42 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 42 | | 3 |
| 72789-551-60 | METFORMIN HYDROCHLORIDE | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 3 |
| 72789-551-90 | METFORMIN HYDROCHLORIDE | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 3 |
| 72789-551-93 | METFORMIN HYDROCHLORIDE | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-551-30 | 72789055130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-30) | 2026-03-13 | No | No | Current |
| 72789-551-42 | 72789055142 | 42 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-42) | 2026-02-26 | No | No | Current |
| 72789-551-60 | 72789055160 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-60) | 2026-02-26 | No | No | Current |
| 72789-551-90 | 72789055190 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-90) | 2026-02-26 | No | No | Current |
| 72789-551-93 | 72789055193 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-551-93) | 2026-02-26 | No | No | Current |