Amlodipine Besylate
- Product NDC
- 50090-3102
- 11-digit product format
- 500903102
- Labeler code
- 50090
- Product ID
- 50090-3102_15f41856-bb89-403e-9b41-1cd39c5f1785
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA077955
- Marketing category
- ANDA
- Marketing start
- 2016-07-01
- 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
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 50090-3102-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-baf4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-3102-0 | Amlodipine Besylate | 33 in 1 BOX, UNIT-DOSE | TABLET | 33 | 3 | |
| 50090-3102-0 | Amlodipine Besylate | 1 in 1 BLISTER PACK | TABLET | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3102 | AMLODIPINE BESYLATE TABLET [A-S MEDICATION SOLUTIONS] | 3 | Legacy NDC, 2 package rows | 20180820_6e943f3c-f894-47f6-8d08-8d1ec8d617af.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | 6e943f3c-f894-47f6-8d08-8d1ec8d617af | 3 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | 6e943f3c-f894-47f6-8d08-8d1ec8d617af | 3 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | 6e943f3c-f894-47f6-8d08-8d1ec8d617af | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50090-3102-0 | 50090310200 | 33 in 1 BOX, UNIT-DOSE | Historical |