Metformin Hydrochloride
- Product NDC
- 25000-101
- 11-digit product format
- 250000101
- Labeler code
- 25000
- Product ID
- 25000-101_5677b344-2a98-49d0-8919-66ee81845c54
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- 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
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-101-03 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 14 |
| 25000-101-12 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 14 |
| 25000-101-14 | Metformin Hydrochloride | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | | 14 |
| 25000-101-97 | Metformin Hydrochloride | 2000 in 1 BAG | TABLET, EXTENDED RELEASE | 2000 | | 14 |
| 25000-101-97 | Metformin Hydrochloride | 4 in 1 BOX | TABLET, EXTENDED RELEASE | 4 | | 14 |
| 25000-101-98 | Metformin Hydrochloride | 1 in 1 BOX | TABLET, EXTENDED RELEASE | 1 | | 14 |
| 25000-101-98 | Metformin Hydrochloride | 11695 in 1 BAG | TABLET, EXTENDED RELEASE | 11695 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25000-101 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [MARKSANS PHARMA LIMITED] | 12 | Current NDC, Legacy NDC, 7 package rows | 20220628_d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 25000-101-03 | 25000010103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-03) | | 2016-05-12 | 0000-00-00 | No | No | Current |
| 25000-101-12 | 25000010112 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-12) | | 2016-05-12 | 0000-00-00 | No | No | Current |
| 25000-101-14 | 25000010114 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-14) | | 2022-06-24 | 0000-00-00 | No | No | Current |
| 25000-101-97 | 25000010197 | 4 BAG in 1 BOX (25000-101-97) / 2000 TABLET, EXTENDED RELEASE in 1 BAG | 4 bag | 2016-05-12 | 0000-00-00 | No | No | Current |
| 25000-101-98 | 25000010198 | 1 BAG in 1 BOX (25000-101-98) / 11695 TABLET, EXTENDED RELEASE in 1 BAG | 1 bag | 2016-05-12 | 0000-00-00 | No | No | Current |