Metformin Hydrochloride
- Product NDC
- 0378-7187
- 11-digit product format
- 003787187
- Labeler code
- 0378
- Product ID
- 0378-7187_bd9cf158-94b6-42b0-b2d6-7d185b6ac310
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA075973
- Marketing category
- ANDA
- Marketing start
- 2010-06-03
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7187-05 | Metformin Hydrochloride | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 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 [MYLAN PHARMACEUTICALS INC.] | 6 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| BLACKBERRY | INACTIVE INGREDIENT | 8A6OMU3I8L | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7187 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 14 | Current NDC, Legacy NDC, 1 package rows | 20240712_4f70f907-08d5-4c2e-a4be-32c6124faa7b.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 |
|---|
| 0378-7187-05 | 00378718705 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7187-05) | 2010-06-03 | 0000-00-00 | No | No | Current |