Metformin Hydrochloride
- Product NDC
- 72789-472
- 11-digit product format
- 727890472
- Labeler code
- 72789
- Product ID
- 72789-472_48d8b1f8-4718-b4ca-e063-6394a90ad35f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA206145
- Marketing category
- ANDA
- Marketing start
- 2018-10-27
- 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 |
|---|
| 72789-472-01 | Metformin Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 25 |
| 72789-472-82 | Metformin Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 500 | | 25 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-472 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 24 | Current NDC, 2 package rows | 20250119_64650d2c-2bec-4470-b250-29d01caa1ebe.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-472-01 | 72789047201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-472-01) | 2025-01-15 | No | No | Historical |
| 72789-472-82 | 72789047282 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-472-82) | 2025-01-15 | No | No | Historical |