Amlodipine Besylate
- Product NDC
- 29300-396
- 11-digit product format
- 293000396
- Labeler code
- 29300
- Product ID
- 29300-396_0f1b84e6-292c-4f46-b475-26c4dec1fbc2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unichem Pharmaceuticals (USA), Inc.
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2019-05-22
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 864V2Q084H |
| Rxcui | 197361, 308135, 308136 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 29300-396-05 | Amlodipine Besylate | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 4 |
| 29300-396-10 | Amlodipine Besylate | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 4 |
| 29300-396-19 | Amlodipine Besylate | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 29300-396 | AMLODIPINE BESYLATE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20221206_a516b336-8f60-4b86-8921-c7d6c07629f2.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 |
|---|
| 29300-396-05 | 29300039605 | 500 TABLET in 1 BOTTLE, PLASTIC (29300-396-05) | 500 tablet | 2020-06-22 | 0000-00-00 | No | No | Current |
| 29300-396-10 | 29300039610 | 1000 TABLET in 1 BOTTLE, PLASTIC (29300-396-10) | 1000 tablet | 2020-06-22 | 0000-00-00 | No | No | Current |
| 29300-396-19 | 29300039619 | 90 TABLET in 1 BOTTLE, PLASTIC (29300-396-19) | 90 tablet | 2020-06-22 | 0000-00-00 | No | No | Current |