Metformin Hydrochloride
- Product NDC
- 72578-035
- 11-digit product format
- 725780035
- Labeler code
- 72578
- Product ID
- 72578-035_54b4a378-d02a-46c6-8b82-1ed5fdea55fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Viona Pharmaceuticals Inc
- Application
- ANDA077060
- Marketing category
- ANDA
- Marketing start
- 2019-03-15
- 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 |
|---|
| 72578-035-01 | Metformin Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 6 |
| 72578-035-05 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72578-035 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [VIONA PHARMACEUTICALS INC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20231121_85027e6c-d35b-49eb-a234-dd71aa77aee0.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 |
|---|
| 72578-035-01 | 72578003501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-035-01) | 2019-03-15 | 0000-00-00 | No | No | Current |
| 72578-035-05 | 72578003505 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72578-035-05) | 2019-03-15 | 0000-00-00 | No | No | Current |