AMLODIPINE BESYLATE
- Product NDC
- 72789-262
- 11-digit product format
- 727890262
- Labeler code
- 72789
- Product ID
- 72789-262_41d6707a-c54e-5987-e063-6294a90ab185
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078414
- Marketing category
- ANDA
- Marketing start
- 2021-10-01
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 10 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
- Brand name suffix
- 10 mg
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMLODIPINE BESYLATE | 10 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 |
|---|
| 72789-262-30 | AMLODIPINE BESYLATE10 mg | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 17 |
| 72789-262-60 | AMLODIPINE BESYLATE10 mg | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 17 |
| 72789-262-90 | AMLODIPINE BESYLATE10 mg | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 17 |
| 72789-262-95 | AMLODIPINE BESYLATE10 mg | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-262 | AMLODIPINE BESYLATE 5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 2.5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [PD-RX PHARMACEUTICALS, INC.] | 16 | Current NDC, Legacy NDC, 4 package rows | 20250121_1080fcea-a5da-499d-a855-690c13559071.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 |
|---|
| 72789-262-30 | 72789026230 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-262-30) | 30 tablet | 2023-04-21 | | No | No | Current |
| 72789-262-60 | 72789026260 | 60 TABLET in 1 BOTTLE, PLASTIC (72789-262-60) | 60 tablet | 2023-04-21 | | No | No | Current |
| 72789-262-90 | 72789026290 | 90 TABLET in 1 BOTTLE, PLASTIC (72789-262-90) | 90 tablet | 2022-07-15 | 0000-00-00 | No | No | Current |
| 72789-262-95 | 72789026295 | 1000 TABLET in 1 BOTTLE, PLASTIC (72789-262-95) | 1000 tablet | 2022-07-15 | 0000-00-00 | No | No | Current |