Metformin Hydrochloride
- Product NDC
- 0591-2411
- 11-digit product format
- 005912411
- Labeler code
- 0591
- Product ID
- 0591-2411_1ee5baf7-7aab-473d-bebc-056eb09f5b9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA203755
- Marketing category
- ANDA
- Marketing start
- 2017-05-15
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2411 | METFORMIN HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.] | 11 | Legacy NDC | 20241017_40fa26bc-ee0d-4b6d-9077-f909d84453e6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2411-01 | 00591241101 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-2411-01) | 2017-05-15 | 0000-00-00 | No | No | Current |