Amlodipine Besylate
- Product NDC
- 0603-2109
- 11-digit product format
- 006032109
- Labeler code
- 0603
- Product ID
- 0603-2109_b4e48976-a292-4faa-a07a-9f86269b208d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amlodipine besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA078414
- Marketing category
- ANDA
- Marketing start
- 2010-04-07
- Marketing end
- 2019-06-30
- 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
- 0000-00-00
- 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-2109-02 | EA - Each | 0603-2109 | a8f1d2a4-10d4-41d9-8a28-5d1bed53de6a | 1 | 2012-07-24 |
| 0603-2109-25 | EA - Each | 0603-2109 | 0c993c71-d6dc-40f8-93fa-cd2376396ace | 1 | 2012-07-24 |
| 0603-2109-28 | EA - Each | 0603-2109 | dcc169df-aece-4e57-b955-51f12ba112bb | 1 | 2012-07-24 |
| 0603-2109-32 | EA - Each | 0603-2109 | 9889da0b-f159-4e1a-84f0-075f94f0266a | 1 | 2012-07-24 |
| 0603-2109-34 | EA - Each | 0603-2109 | ccfb1311-788a-4ea9-8282-d16abc86e9b7 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | b3d9dd95-d250-4201-8e95-466fd321c37e | 1 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | b3d9dd95-d250-4201-8e95-466fd321c37e | 1 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | b3d9dd95-d250-4201-8e95-466fd321c37e | 1 |