Metformin Hydrochloride
- Product NDC
- 48433-326
- 11-digit product format
- 484330326
- Labeler code
- 48433
- Product ID
- 48433-326_14f29eeb-4db9-47be-a981-1e9f400a2139
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Safecor Health, LLC
- Application
- ANDA075978
- Marketing category
- ANDA
- Marketing start
- 2014-09-30
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 48433-326-01 | Metformin Hydrochloride | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 1 |
| 48433-326-10 | Metformin Hydrochloride | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 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 [SAFECOR HEALTH, LLC] | 1 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC] | 1 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC] | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC] | 1 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 48433-326 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED [SAFECOR HEALTH, LLC] | 1 | Legacy NDC, 2 package rows | 20141014_14f29eeb-4db9-47be-a981-1e9f400a2139.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 48433-326-01 | 48433032601 | 1 in 1 POUCH | Historical |
| 48433-326-10 | 48433032610 | 100 in 1 BOX, UNIT-DOSE | Historical |