METFORMIN HYDROCHLORIDE
- Product NDC
- 43353-082
- 11-digit product format
- 433530082
- Labeler code
- 43353
- Product ID
- 43353-082_afc5f57d-e5ee-4eef-acb8-00c6fe16ce44
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA203769
- Marketing category
- ANDA
- Marketing start
- 2013-09-11
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-082-30 | METFORMIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
| 43353-082-53 | METFORMIN HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 43353-082-60 | METFORMIN HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | | 6 |
| 43353-082-80 | METFORMIN HYDROCHLORIDE | 180 in 1 BOTTLE | TABLET | 180 | | 6 |
| 43353-082-92 | METFORMIN HYDROCHLORIDE | 270 in 1 BOTTLE | TABLET | 270 | | 6 |
| 43353-082-96 | METFORMIN HYDROCHLORIDE | 450 in 1 BOTTLE | TABLET | 450 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-082 | METFORMIN HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 5 | Legacy NDC, 6 package rows | 20240618_273d86b0-9d30-48c9-8918-c5e1ececa951.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-082-30 | 43353008230 | 30 TABLET in 1 BOTTLE (43353-082-30) | 30 tablet | 2020-05-13 | 0000-00-00 | No | No | Current |
| 43353-082-53 | 43353008253 | 60 TABLET in 1 BOTTLE (43353-082-53) | 60 tablet | 2020-05-13 | 0000-00-00 | No | No | Current |
| 43353-082-60 | 43353008260 | 90 TABLET in 1 BOTTLE (43353-082-60) | 90 tablet | 2015-07-10 | 0000-00-00 | No | No | Current |
| 43353-082-80 | 43353008280 | 180 TABLET in 1 BOTTLE (43353-082-80) | 180 tablet | 2015-07-11 | 0000-00-00 | No | No | Current |
| 43353-082-92 | 43353008292 | 270 TABLET in 1 BOTTLE (43353-082-92) | 270 tablet | 2016-08-16 | 0000-00-00 | No | No | Current |
| 43353-082-96 | 43353008296 | 450 TABLET in 1 BOTTLE (43353-082-96) | 450 tablet | 2020-05-13 | 0000-00-00 | No | No | Current |