NDC 48433-308-01 - Amlodipine Besylate
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 48433-308
- Requested NDC
- 48433-308-01
- Package NDCs from labels
- 48433-308-01, 48433-308-10
- Manufacturer
- Safecor Health, LLC
- Effective date
- 2013-01-01
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Amlodipine Besylate - Safecor Health, LLC | Safecor Health, LLC | 2013-01-01 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| AMLODIPINE BESYLATE | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC] | 1 | |
| AMLODIPINE | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC] | 1 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | AMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMLODIPINE BESYLATE TABLET [SAFECOR HEALTH, LLC] | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | BluePoint Laboratories | df8e23c8-6c8f-4293-8a37-5ad3d48dba94 | 2023-05-03 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| AMLODIPINE BESYLATE 5 mg | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | b597d1e1-aba1-4272-bed7-4c95e8150d58 | 2023-04-19 | Warnings, Adverse reactions | ANDA078414 864V2Q084H |
| Amlodipine besylate | AMLODIPINE BESYLATE | Exelan Pharmaceuticals, Inc. | efd9eda5-f497-45a3-ae13-dee729add999 | 2023-03-23 | Warnings, Adverse reactions | 864V2Q084H |
| Norvasc | AMLODIPINE BESYLATE | Viatris Specialty LLC | 7367289c-b0b0-466a-83e2-558e2985c29f | 2023-02-15 | Warnings, Adverse reactions | 864V2Q084H |
| Telmisartan and Amlodipine | TELMISARTAN AND AMLODIPINE | Alembic Pharmaceuticals Limited | 15b438b4-4874-43f4-a50a-4e6f3e5530ac | 2023-01-30 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine and Valsartan | AMLODIPINE AND VALSARTAN | Alembic Pharmaceuticals Limited | a9c442dc-749e-4de0-bca3-1044eb78da72 | 2023-01-27 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine besylate and Olmesartran medoxomil | AMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMIL | Alembic Pharmaceuticals Limited | cb2df7f7-fee8-42ba-8936-0788c4fcc0cb | 2023-01-23 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | Dr.Reddy's Laboratories Limited | f12f18bb-7ddb-e7dc-4edd-32f4ac212bca | 2022-12-23 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | Dr.Reddy's Laboratories Limited | ca014f06-982c-6fe1-9948-a3701dd35d34 | 2022-12-23 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Unichem Pharmaceuticals (USA), Inc. | a516b336-8f60-4b86-8921-c7d6c07629f2 | 2022-12-05 | Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | 29a0d87e-6afb-4766-9045-1963c5b0d183 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| amlodipine besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | f3482709-c5c3-4bd0-8067-ad57f31bb525 | 2022-10-18 | Warnings, Adverse reactions | 864V2Q084H |
| AMLODIPINE AND VALSARTAN | AMLODIPINE AND VALSARTAN | Lupin Pharmaceuticals,Inc. | e05dd72c-7475-422e-bf8e-73148929450e | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 445d1274-7249-476b-ad90-ff93aee56f6d | 2022-06-01 | Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d6 | 2022-04-01 | Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine besylate | AMLODIPINE BESYLATE | Exelan Pharmaceuticals, Inc. | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 2022-03-12 | Warnings, Adverse reactions | 864V2Q084H |
| AMLODIPINE AND VALSARTAN | AMLODIPINE AND VALSARTAN | Mylan Pharmaceuticals Inc. | aa7e7d95-520a-461c-b1b3-e588aeb6a613 | 2021-08-31 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | c2c51ec3-ffb0-4240-b048-a8e424775a76 | 2021-08-01 | Warnings, Adverse reactions | 864V2Q084H |
| Melange combination | CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA | Seroyal USA | 0a071fbf-0075-4479-e054-00144ff8d46c | 2021-07-14 | Warnings | L11K75P92J |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | afcffa7b-03b7-499a-b50c-37b0e28c7737 | 2021-05-11 | Warnings, Adverse reactions | 864V2Q084H |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.