METFORMIN HYDROCHLORIDE
- Product NDC
- 71610-457
- 11-digit product format
- 716100457
- Labeler code
- 71610
- Product ID
- 71610-457_26802a69-e56c-4a63-add0-178b560cce98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2013-11-01
- 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
- 2021-12-31
- 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 |
|---|
| 71610-457 | METFORMIN HYDROCHLORIDE ER (METFORMIN HYDROCHLORIDE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC | 20201009_f0371d2a-276b-4acb-80f8-e24fb8ceae19.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-457-30 | 71610045730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-30) | 2020-09-11 | 0000-00-00 | No | No | Current |
| 71610-457-53 | 71610045753 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-53) | 2020-09-02 | 0000-00-00 | No | No | Current |
| 71610-457-60 | 71610045760 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-60) | 2020-08-27 | 0000-00-00 | No | No | Current |
| 71610-457-70 | 71610045770 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-70) | 2020-08-27 | 0000-00-00 | No | No | Current |
| 71610-457-80 | 71610045780 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-80) | 2020-08-27 | 0000-00-00 | No | No | Current |
| 71610-457-92 | 71610045792 | 270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-92) | 2020-08-27 | 0000-00-00 | No | No | Current |
| 71610-457-94 | 71610045794 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-457-94) | 2020-09-11 | 0000-00-00 | No | No | Current |