Metformin Hydrochloride
- Product NDC
- 10544-058
- 11-digit product format
- 105440058
- Labeler code
- 10544
- Product ID
- 10544-058_112e1e53-1ced-0f7e-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA075978
- Marketing category
- ANDA
- Marketing start
- 2003-04-17
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 10544-058-30 | Metformin Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
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 [BLENHEIM PHARMACAL, INC.] | 1 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-058 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 1 package rows | 20150313_112e1e53-1cec-0f7e-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-058-30 | 10544005830 | 30 in 1 BOTTLE | Historical |