Metformin Hydrochloride
- Product NDC
- 43547-358
- 11-digit product format
- 435470358
- Labeler code
- 43547
- Product ID
- 43547-358_186ad68d-1bb3-437c-8c4e-4d1ef6ed52c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco Healthcare U.S., LLC
- Application
- ANDA203769
- Marketing category
- ANDA
- Marketing start
- 2014-10-15
- Marketing end
- 2020-10-03
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 mg/1
- Pharmacologic classes
- Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43547-358-10 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-6568-f424-e053-dadaa90a57ce | b741ccd1-dfc1-42ad-9bf8-3f98ffd3055b |
| 43547-358-50 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-6568-f424-e053-dadaa90a57ce | b741ccd1-dfc1-42ad-9bf8-3f98ffd3055b |
| 43547-358-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6568-f424-e053-dadaa90a57ce | b741ccd1-dfc1-42ad-9bf8-3f98ffd3055b |
| 43547-358-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6568-f424-e053-dadaa90a57ce | b741ccd1-dfc1-42ad-9bf8-3f98ffd3055b |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-358-10 | EA - Each | 43547-358 | 98073d6c-87c6-43c4-9783-2ca658c73566 | 1 | 2014-11-05 |
| 43547-358-50 | EA - Each | 43547-358 | 3e821d3d-6ac8-4adc-a4ad-e1e39007d9d5 | 1 | 2014-11-05 |