Metformin Hydrochloride
- Product NDC
- 25000-132
- 11-digit product format
- 250000132
- Labeler code
- 25000
- Product ID
- 25000-132_772a3f8d-481d-429f-8d11-0a08a1d84304
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- MARKSANS PHARMA LIMITED
- Application
- ANDA090888
- Marketing category
- ANDA
- Marketing start
- 2012-06-01
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 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 | 1000 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25000-132-03 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 15 |
| 25000-132-12 | Metformin Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 15 |
| 25000-132-53 | Metformin Hydrochloride | 1500 in 1 BAG | TABLET, FILM COATED | 1500 | | 15 |
| 25000-132-98 | Metformin Hydrochloride | 1 in 1 BOX | TABLET, FILM COATED | 1 | | 15 |
| 25000-132-98 | Metformin Hydrochloride | 8225 in 1 BAG | TABLET, FILM COATED | 8225 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METFORMIN HYDROCHLORIDE | ACTIVE INGREDIENT | 786Z46389E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 9 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 9 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 9 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 9 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 9 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25000-132 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MARKSANS PHARMA LIMITED] | 14 | Current NDC, Legacy NDC, 5 package rows | 20250227_b8004451-7b26-425b-b5ea-cbb1b08e30e3.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 |
|---|
| 25000-132-03 | 25000013203 | 30 TABLET, FILM COATED in 1 BOTTLE (25000-132-03) | | 2012-06-01 | 0000-00-00 | No | No | Current |
| 25000-132-12 | 25000013212 | 500 TABLET, FILM COATED in 1 BOTTLE (25000-132-12) | | 2012-06-01 | 0000-00-00 | No | No | Current |
| 25000-132-53 | 25000013253 | 1500 TABLET, FILM COATED in 1 BAG (25000-132-53) | | 2012-06-01 | 0000-00-00 | No | No | Current |
| 25000-132-98 | 25000013298 | 1 BAG in 1 BOX (25000-132-98) / 8225 TABLET, FILM COATED in 1 BAG | 1 bag | 2012-06-01 | 0000-00-00 | No | No | Current |