METFORMIN HYDROCHLORIDE EXTENDED RELEASE
- Product NDC
- 72789-009
- 11-digit product format
- 727890009
- Labeler code
- 72789
- Product ID
- 72789-009_3143f509-5529-ee8b-e063-6294a90aeed3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA090295
- Marketing category
- ANDA
- Marketing start
- 2016-05-12
- 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 EXTENDED RELEASE
- 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 |
|---|
| 72789-009-30 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 18 |
| 72789-009-60 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 60 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 60 | | 18 |
| 72789-009-90 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 18 |
| 72789-009-93 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE | 180 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 180 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-009 | METFORMIN HYDROCHLORIDE EXTENDED RELEASE (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 18 | Current NDC, Legacy NDC, 4 package rows | 20250328_14f3091c-f243-4364-b433-727c7d4ef8d5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 72789-009-30 | 72789000930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-30) | 2019-09-18 | 0000-00-00 | No | No | Current |
| 72789-009-60 | 72789000960 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-60) | 2019-09-20 | 0000-00-00 | No | No | Current |
| 72789-009-90 | 72789000990 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-90) | 2019-09-13 | 0000-00-00 | No | No | Current |
| 72789-009-93 | 72789000993 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-93) | 2019-09-13 | 0000-00-00 | No | No | Current |