Metformin Hydrochloride
- Product NDC
- 43063-428
- 11-digit product format
- 430630428
- Labeler code
- 43063
- Product ID
- 43063-428_8d6a42ac-943e-7265-e053-2995a90a49c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078596
- Marketing category
- ANDA
- Marketing start
- 2009-12-02
- 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43063-428-30 | EA - Each | 43063-428 | a54f6704-365a-4b5e-8e91-06ea14b902d7 | 1 | 2013-05-02 |
| 43063-428-60 | EA - Each | 43063-428 | 57fe6e40-8811-4653-95eb-5bd169f5c794 | 1 | 2015-09-10 |
| 43063-428-90 | EA - Each | 43063-428 | 573c7a4b-f9c7-49c3-9117-f7931c66c5d1 | 1 | 2013-02-13 |
| 43063-428-93 | EA - Each | 43063-428 | a5d2fbc8-eec6-41c7-8309-7311c1d0de89 | 1 | 2013-02-13 |
| 43063-428-94 | EA - Each | 43063-428 | b3bf1c52-5d21-4f85-ade9-c4cafcc7d4fb | 1 | 2013-02-13 |
| 43063-428-98 | EA - Each | 43063-428 | 0b875261-3d25-4965-90f6-cb5734340176 | 1 | 2017-10-13 |