Metformin hydrochloride
- Product NDC
- 72789-106
- 11-digit product format
- 727890106
- Labeler code
- 72789
- Product ID
- 72789-106_4d516be1-a3c2-b794-e063-6394a90afb7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA207427
- Marketing category
- ANDA
- Marketing start
- 2018-06-28
- 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
- Brand name suffix
- ER
- 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 | 860975, 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-106-01 | Metformin hydrochlorideER | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 23 |
| 72789-106-82 | Metformin hydrochlorideER | 500 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 500 | | 23 |
| 72789-106-90 | Metformin hydrochlorideER | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 23 |
| 72789-106-93 | Metformin hydrochlorideER | 180 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 180 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-106 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE METFORMIN HYDROCHLORIDE ER (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 20 | Current NDC, Legacy NDC, 4 package rows | 20240829_17050df5-9e95-4e1b-ac75-34add289b139.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 |
|---|
| 72789-106-01 | 72789010601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-106-01) | 2020-04-20 | 0000-00-00 | No | No | Current |
| 72789-106-82 | 72789010682 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-106-82) | 2020-01-29 | 0000-00-00 | No | No | Current |
| 72789-106-90 | 72789010690 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-106-90) | 2020-08-24 | 0000-00-00 | No | No | Current |
| 72789-106-93 | 72789010693 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-106-93) | 2020-08-24 | 0000-00-00 | No | No | Current |
| 72789-106-95 | 72789010695 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-106-95) | 2021-01-29 | 0000-00-00 | No | No | Current |