Metformin Hydrochloride
- Product NDC
- 72789-454
- 11-digit product format
- 727890454
- Labeler code
- 72789
- Product ID
- 72789-454_47ce08ef-0eaa-9afc-e063-6394a90a8b55
- 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
- 500 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 | 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 |
|---|
| 72789-454-60 | Metformin Hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 60 | | 5 |
| 72789-454-90 | Metformin Hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 5 |
| 72789-454-93 | Metformin Hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 180 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-454 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 2 | Current NDC, 3 package rows | 20241207_68d0b1a6-c99e-42cf-afdf-b71ee73c4424.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-454-60 | 72789045460 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-454-60) | 2025-08-11 | No | No | Current |
| 72789-454-90 | 72789045490 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-454-90) | 2024-12-04 | No | No | Current |
| 72789-454-93 | 72789045493 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-454-93) | 2025-08-19 | No | No | Current |