Metformin Hydrochloride
- Product NDC
- 71610-304
- 11-digit product format
- 716100304
- Labeler code
- 71610
- Product ID
- 71610-304_cb53bf6d-c6d6-4913-98bb-0f161d32119b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- 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 Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-304-80 | Metformin Hydrochloride | 180 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 180 | | 1 |
| 71610-304-94 | Metformin Hydrochloride | 360 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 360 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-304 | METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 2 package rows | 20190718_3de79b9f-6dc9-400f-b44e-c12921ac824b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-304-80 | 71610030480 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-304-80) | 2019-07-16 | 0000-00-00 | No | No | Current |
| 71610-304-94 | 71610030494 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-304-94) | 2019-07-15 | 0000-00-00 | No | No | Current |