Amlodipine Besylate
- Product NDC
- 72789-515
- 11-digit product format
- 727890515
- Labeler code
- 72789
- Product ID
- 72789-515_5118f5b1-9768-ddc2-e063-6394a90a4b58
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA076719
- Marketing category
- ANDA
- Marketing start
- 2007-05-23
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amlodipine Besylate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMLODIPINE BESYLATE | 5 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 864V2Q084H |
| Rxcui | 197361, 308135, 308136 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fa898d56-9495-d6f0-309b-68a5d8e3914a | Product name | 4 | 20260305 |
| c19ec24d-2c40-4b8d-7c20-500ffa3660a1 | Product name | 3 | 20260303 |
| b15e9aa6-d523-ca97-480e-570e0543a342 | Product name | 4 | 20251024 |
| 265792b3-b999-c010-7364-a7db20b9d4d9 | Product name | 5 | 20250515 |
| 14c2c15b-f823-4ada-a40e-a440544294dc | Product name | 1 | 20221207 |
| a72887ef-d675-499f-af4b-78688f6855cd | Product name | 1 | 20191002 |
| a4484670-2869-6416-f6ff-03b1b3cbd1b0 | Product name | 2 | 20190415 |
| 4a27501f-a987-48a5-99b4-e983d4744d76 | Product name | 7 | 20181211 |
| 18600d07-613d-bf9c-2711-fe40c06f3393 | Product name | 5 | 20180703 |
| bded1554-44de-900a-5297-403365d6d4b2 | Product name | 3 | 20170110 |
| 1f1c6e4b-bbad-4649-afd1-7a1d671db4b1 | Product name | 1 | 20150316 |
| 63ab5fbf-2a6b-c41d-051a-39e845d718b1 | Product name | 1 | 20140508 |
| 7613b1a5-acb6-4e5e-6048-c44deeeb1212 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72789-515-30 | Amlodipine Besylate | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 9 | |
| 72789-515-60 | Amlodipine Besylate | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 9 | |
| 72789-515-90 | Amlodipine Besylate | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 9 | |
| 72789-515-95 | Amlodipine Besylate | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72789-515-30 | EA - Each | 72789-515 | 46ff6953-16ef-4c2d-b66f-a9b8ec8c721f | 1 | 2025-12-16 |
| 72789-515-60 | EA - Each | 72789-515 | 83cae760-9d4f-4111-8c51-5212467c7e4c | 1 | 2026-04-20 |
| 72789-515-90 | EA - Each | 72789-515 | fe877340-9e2f-41b3-823d-cd3f70816238 | 1 | 2025-12-16 |
| 72789-515-95 | EA - Each | 72789-515 | 00d56aa9-0774-40fc-b3e1-e47e265eca26 | 1 | 2025-08-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308135 | amLODIPine besylate 10 MG Oral Tablet | PSN | 5a0b3dd4-91f5-4173-a992-e91b1cac6a18 | 9 |
| 308136 | amLODIPine besylate 2.5 MG Oral Tablet | PSN | 5a0b3dd4-91f5-4173-a992-e91b1cac6a18 | 9 |
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | 5a0b3dd4-91f5-4173-a992-e91b1cac6a18 | 9 |
| 308135 | amlodipine 10 MG Oral Tablet | SCD | 5a0b3dd4-91f5-4173-a992-e91b1cac6a18 | 9 |
| 308136 | amlodipine 2.5 MG Oral Tablet | SCD | 5a0b3dd4-91f5-4173-a992-e91b1cac6a18 | 9 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | 5a0b3dd4-91f5-4173-a992-e91b1cac6a18 | 9 |
| 308135 | amlodipine (as amlodipine besylate) 10 MG Oral Tablet | SY | 5a0b3dd4-91f5-4173-a992-e91b1cac6a18 | 9 |
| 308136 | amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet | SY | 5a0b3dd4-91f5-4173-a992-e91b1cac6a18 | 9 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | 5a0b3dd4-91f5-4173-a992-e91b1cac6a18 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72789-515-30 | 72789051530 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-515-30) | 30 tablet | 2025-10-24 | No | No | Current |
| 72789-515-60 | 72789051560 | 60 TABLET in 1 BOTTLE, PLASTIC (72789-515-60) | 60 tablet | 2026-03-04 | No | No | Current |
| 72789-515-90 | 72789051590 | 90 TABLET in 1 BOTTLE, PLASTIC (72789-515-90) | 90 tablet | 2025-10-20 | No | No | Current |
| 72789-515-95 | 72789051595 | 1000 TABLET in 1 BOTTLE, PLASTIC (72789-515-95) | 1000 tablet | 2025-06-26 | No | No | Current |