AMLODIPINE BESYLATE
- Product NDC
- 61919-844
- 11-digit product format
- 619190844
- Labeler code
- 61919
- Product ID
- 61919-844_c936cb53-35a5-d89d-e053-2a95a90a2701
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AMLODIPINE BESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DirectRX
- Application
- ANDA203245
- Marketing category
- ANDA
- Marketing start
- 2015-01-01
- Marketing end
- 0000-00-00
- Substance
- AMLODIPINE BESYLATE
- Active strength
- 5 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
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-844-30 | 2025-01-30 | C162847 | 48780-1 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-71 | 2025-01-30 | C162847 | 48780-1 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-90 | 2025-01-30 | C162847 | 48780-1 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-60 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6ed9-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-71 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
| 61919-844-90 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0fa0-111a-e063-dadaa90a10e2 | AMLODIPINE BESYLATE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-844-30 | AMLODIPINE BESYLATE | 30 in 1 BOTTLE | TABLET | 30 | 5 | |
| 61919-844-71 | AMLODIPINE BESYLATE | 100 in 1 BOTTLE | TABLET | 100 | 5 | |
| 61919-844-90 | AMLODIPINE BESYLATE | 90 in 1 BOTTLE | TABLET | 90 | 5 | |
| 61919-844-60 | AMLODIPINE BESYLATE | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-844 | AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE TABLET [DIRECTRX] | 5 | Legacy NDC, 3 package rows | 20210811_b2ce9cd0-1c79-4b35-b87b-daff2c381a73.zip |
| 61919-844 | AMLODIPINE BESYLATE TABLET [DIRECT_RX] | 1 | Legacy NDC, 1 package rows | 20190730_8ed46bb1-9fc9-4418-e053-2a95a90abd4b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308135 | amLODIPine besylate 10 MG Oral Tablet | PSN | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 308135 | amlodipine 10 MG Oral Tablet | SCD | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 308135 | amlodipine (as amlodipine besylate) 10 MG Oral Tablet | SY | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | b2ce9cd0-1c79-4b35-b87b-daff2c381a73 | 5 |
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | 8ed46bb1-9fc9-4418-e053-2a95a90abd4b | 1 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | 8ed46bb1-9fc9-4418-e053-2a95a90abd4b | 1 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | 8ed46bb1-9fc9-4418-e053-2a95a90abd4b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-844-30 | 61919084430 | 30 TABLET in 1 BOTTLE (61919-844-30) | 30 tablet | 2015-01-01 | 0000-00-00 | No | No | Current |
| 61919-844-60 | 61919084460 | 60 TABLET in 1 BOTTLE (61919-844-60) | 60 tablet | 2019-07-29 | 0000-00-00 | No | No | Current |
| 61919-844-71 | 61919084471 | 100 TABLET in 1 BOTTLE (61919-844-71) | 100 tablet | 2015-01-01 | 0000-00-00 | No | No | Current |
| 61919-844-90 | 61919084490 | 90 TABLET in 1 BOTTLE (61919-844-90) | 90 tablet | 2015-12-28 | 0000-00-00 | No | No | Current |