Metformin Hydrochloride
- Product NDC
- 43547-321
- 11-digit product format
- 435470321
- Labeler code
- 43547
- Product ID
- 43547-321_08297a45-dcc8-469a-9276-4490f078d303
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Solco healthcare U.S., LLC
- Application
- ANDA090888
- Marketing category
- ANDA
- Marketing start
- 2013-04-15
- Marketing end
- 0000-00-00
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43547-321-00 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-5c9e-f424-e053-dadaa90a57ce | 6046ecd6-db16-4683-9e84-1d2b0085f55e |
| 43547-321-10 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-5c9e-f424-e053-dadaa90a57ce | 6046ecd6-db16-4683-9e84-1d2b0085f55e |
| 43547-321-11 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-5c9e-f424-e053-dadaa90a57ce | 6046ecd6-db16-4683-9e84-1d2b0085f55e |
| 43547-321-50 | 2020-04-07 | C162847 | 48780-1 | 9d75b9d0-5c9e-f424-e053-dadaa90a57ce | 6046ecd6-db16-4683-9e84-1d2b0085f55e |
| 43547-321-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5c9e-f424-e053-dadaa90a57ce | 6046ecd6-db16-4683-9e84-1d2b0085f55e |
| 43547-321-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5c9e-f424-e053-dadaa90a57ce | 6046ecd6-db16-4683-9e84-1d2b0085f55e |
| 43547-321-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5c9e-f424-e053-dadaa90a57ce | 6046ecd6-db16-4683-9e84-1d2b0085f55e |
| 43547-321-50 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-5c9e-f424-e053-dadaa90a57ce | 6046ecd6-db16-4683-9e84-1d2b0085f55e |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-321-10 | EA - Each | 43547-321 | f2d47270-e4da-415c-82de-551f801a9f77 | 1 | 2014-05-02 |
| 43547-321-50 | EA - Each | 43547-321 | fad9edfb-afca-4d46-a6ca-e605e96f74b3 | 1 | 2013-05-02 |