AMLODIPINE BESYLATE
- Product NDC
- 68071-1980
- 11-digit product format
- 680711980
- Labeler code
- 68071
- Product ID
- 68071-1980_bc065631-3102-076c-e053-2995a90aef4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA077073
- Marketing category
- ANDA
- Marketing start
- 2007-09-26
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AMLODIPINE BESYLATE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 10 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 864V2Q084H |
FDA-Initiated Inactive NDC Indexing#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68071-1980-2 | 68071198002 | 120 TABLET in 1 BOTTLE (68071-1980-2) | 120 tablet | 2017-02-22 | 0000-00-00 | No | No | Current |
| 68071-1980-3 | 68071198003 | 30 TABLET in 1 BOTTLE (68071-1980-3) | 30 tablet | 2017-02-22 | 0000-00-00 | No | No | Current |
| 68071-1980-6 | 68071198006 | 60 TABLET in 1 BOTTLE (68071-1980-6) | 60 tablet | 2017-02-22 | 0000-00-00 | No | No | Current |
| 68071-1980-9 | 68071198009 | 90 TABLET in 1 BOTTLE (68071-1980-9) | 90 tablet | 2017-02-22 | 0000-00-00 | No | No | Current |