Amlodipine besylate
- Product NDC
- 76282-507
- 11-digit product format
- 762820507
- Labeler code
- 76282
- Product ID
- 76282-507_17a72ab9-cae7-43c3-9913-fff5e038970b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc.
- Application
- ANDA206367
- Marketing category
- ANDA
- Marketing start
- 2022-03-15
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|
| 76282-507-05 | Amlodipine besylate | 500 in 1 BOTTLE | TABLET | 500 | 1 | |
| 76282-507-10 | Amlodipine besylate | 1000 in 1 BOTTLE | TABLET | 1000 | 1 | |
| 76282-507-90 | Amlodipine besylate | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76282-507-10 | EA - Each | 76282-507 | 461a74c5-c66b-4147-b61b-862e22dbeb2f | 1 | 2024-03-12 |
| 76282-507-90 | EA - Each | 76282-507 | e7ab4562-d9c8-43cc-87e6-0d4f0b84170f | 1 | 2024-09-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308135 | amLODIPine besylate 10 MG Oral Tablet | PSN | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 1 |
| 308136 | amLODIPine besylate 2.5 MG Oral Tablet | PSN | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 1 |
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 1 |
| 308135 | amlodipine 10 MG Oral Tablet | SCD | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 1 |
| 308136 | amlodipine 2.5 MG Oral Tablet | SCD | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 1 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 1 |
| 308135 | amlodipine (as amlodipine besylate) 10 MG Oral Tablet | SY | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 1 |
| 308136 | amlodipine (as amlodipine besylate) 2.5 MG Oral Tablet | SY | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 1 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76282-507-05 | 76282050705 | 500 TABLET in 1 BOTTLE (76282-507-05) | 500 tablet | 2022-03-15 | 0000-00-00 | No | No | Current |
| 76282-507-10 | 76282050710 | 1000 TABLET in 1 BOTTLE (76282-507-10) | 1000 tablet | 2022-03-15 | 0000-00-00 | No | No | Current |
| 76282-507-90 | 76282050790 | 90 TABLET in 1 BOTTLE (76282-507-90) | 90 tablet | 2022-03-15 | 0000-00-00 | No | No | Current |