Amlodipine Besylate
- Product NDC
- 66116-446
- 11-digit product format
- 661160446
- Labeler code
- 66116
- Product ID
- 66116-446_213502a2-f667-4da6-a4b9-462eb303c401
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amlodipine Besylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MedVantx, Inc.
- Application
- ANDA076846
- Marketing category
- ANDA
- Marketing start
- 2010-03-23
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 66116-446-30 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b621-f6ea-e053-dbdaa90aa703 | 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 use Initial U.S. Approval: 1987 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66116-446-30 | Amlodipine Besylate | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET [MEDVANTX, INC.] | 1 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [MEDVANTX, INC.] | 1 | |
| ANHYDROUS DIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET [MEDVANTX, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [MEDVANTX, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [MEDVANTX, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [MEDVANTX, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197361 | amLODIPine besylate 5 MG Oral Tablet | PSN | 213502a2-f667-4da6-a4b9-462eb303c401 | 1 |
| 197361 | amlodipine 5 MG Oral Tablet | SCD | 213502a2-f667-4da6-a4b9-462eb303c401 | 1 |
| 197361 | amlodipine (as amlodipine besylate) 5 MG Oral Tablet | SY | 213502a2-f667-4da6-a4b9-462eb303c401 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 66116-446-30 | 66116044630 | 30 in 1 BOTTLE | Historical |