METFORMIN HYDROCHLORIDE
- Product NDC
- 72789-455
- 11-digit product format
- 727890455
- Labeler code
- 72789
- Product ID
- 72789-455_3cf839a3-34a6-736c-e063-6394a90a8ae5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METFORMIN HYDROCHLORIDE
- Listing expiration
- 2026-12-31
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 |
|---|
| 72789-455-30 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-455 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 6 | Current NDC, 1 package rows | 20241208_f55a245b-a786-4a4a-b11c-c61d48294b01.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-455-30 | 72789045530 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-455-30) | 2024-12-05 | No | No | Current |