Metformin Hydrochloride
- Product NDC
- 72789-451
- 11-digit product format
- 727890451
- Labeler code
- 72789
- Product ID
- 72789-451_47ba4996-d987-5e87-e063-6394a90a0554
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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 | 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 |
|---|
| 72789-451-30 | Metformin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 4 |
| 72789-451-60 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-451 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | Current NDC, 2 package rows | 20250122_41408f64-d366-403e-9595-464ab25c6f97.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-451-30 | 72789045130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-451-30) | 2025-01-20 | No | No | Current |
| 72789-451-60 | 72789045160 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-451-60) | 2024-11-25 | No | No | Current |