Metformin Hydrochloride
- Product NDC
- 0591-2719
- 11-digit product format
- 005912719
- Labeler code
- 0591
- Product ID
- 0591-2719_ba0272a1-f364-42bf-a536-f3fdd4caee48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA021574
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-04-18
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| METFORMIN | ACTIVE MOIETY | 9100L32L2N | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| CELLULOSE ACETATE | INACTIVE INGREDIENT | 3J2P07GVB6 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2719 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 10 | Legacy NDC | 20190116_5c59e295-8529-4402-81f7-d86047fde848.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2719-60 | 00591271960 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2719-60) | 2012-04-18 | 0000-00-00 | No | No | Current |