Metformin hydrochloride
- Product NDC
- 72789-105
- 11-digit product format
- 727890105
- Labeler code
- 72789
- Product ID
- 72789-105_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
- 2018-07-17
- 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, 860981 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-105-01 | Metformin hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 23 |
| 72789-105-60 | Metformin hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 60 | | 23 |
| 72789-105-82 | Metformin hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 500 | | 23 |
| 72789-105-90 | Metformin hydrochloride | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 23 |
| 72789-105-93 | Metformin hydrochloride | 180 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 180 | | 23 |
| 72789-105-95 | Metformin hydrochloride | 1000 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 1000 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-105 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE METFORMIN HYDROCHLORIDE ER (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 20 | Current NDC, Legacy NDC, 6 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 |
|---|
| 72789-105-01 | 72789010501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-01) | 2021-05-10 | 0000-00-00 | No | No | Current |
| 72789-105-60 | 72789010560 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-60) | 2023-05-22 | | No | No | Current |
| 72789-105-82 | 72789010582 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-82) | 2021-01-29 | 0000-00-00 | No | No | Current |
| 72789-105-90 | 72789010590 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-90) | 2020-08-24 | 0000-00-00 | No | No | Current |
| 72789-105-93 | 72789010593 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-93) | 2020-08-24 | 0000-00-00 | No | No | Current |
| 72789-105-95 | 72789010595 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-105-95) | 2021-01-29 | 0000-00-00 | No | No | Current |