Amlodipine Besylate
- Product NDC
- 43353-691
- 11-digit product format
- 433530691
- Labeler code
- 43353
- Product ID
- 43353-691_1fb58ec3-f97b-443f-ada2-a8d4edaedef8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078414
- Marketing category
- ANDA
- Marketing start
- 2010-04-07
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-691 | AMLODIPINE BESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | Legacy NDC | 20171026_6e83de08-b0f6-492a-a2db-e8d33a7a28aa.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43353-691-30 | 43353069130 | 30 TABLET in 1 BOTTLE, PLASTIC (43353-691-30) | 30 tablet | 2010-12-22 | 0000-00-00 | No | No | Current |
| 43353-691-45 | 43353069145 | 45 TABLET in 1 BOTTLE, PLASTIC (43353-691-45) | 45 tablet | 2015-09-18 | 0000-00-00 | No | No | Current |
| 43353-691-60 | 43353069160 | 90 TABLET in 1 BOTTLE, PLASTIC (43353-691-60) | 90 tablet | 2015-12-11 | 0000-00-00 | No | No | Current |