NDC 68071-3453-02 - AMLODIPINE BESYLATE 10 mg
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
- 68071-3453
- Requested NDC
- 68071-3453-02
- Package NDCs from labels
- 68071-3453-2, 68071-3453-9, 68071-3453-3, 68071-3453-02
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2024-03-26
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| AMLODIPINE BESYLATE 10 mg - NuCare Pharmaceuticals,Inc. | NuCare Pharmaceuticals,Inc. | 2024-03-26 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-3453-2 | AMLODIPINE BESYLATE10 mg | 120 in 1 BOTTLE | TABLET | 120 | 3 | |
| 68071-3453-3 | AMLODIPINE BESYLATE10 mg | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 68071-3453-9 | AMLODIPINE BESYLATE10 mg | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-3453 | AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, 3 package rows | 20240328_ffe96aa1-db66-33e4-e053-6394a90a7e4e.zip |
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 | REMEDYREPACK INC. | 0f253cac-67ac-4b03-b1a8-f2c345938dda | 2026-09-09 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | REMEDYREPACK INC. | dc206611-5188-40a6-b025-61db41f68a5a | 2026-09-09 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate and Benazepril Hydrochloride | AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE | REMEDYREPACK INC. | 2542895b-c8f8-4f21-9e12-f5a7fe17f905 | 2026-09-09 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Coupler LLC | 5af8493b-2b73-859c-e063-6394a90a4620 | 2026-09-08 | Warnings, Adverse reactions | 308135 864V2Q084H |
| Amlodipine and Atorvastatin | AMLODIPINE AND ATORVASTATIN | Apotex Corp. | 4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b03 | 2026-09-03 | Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | GSMS, Incorporated | 9c0f83f4-06ad-4bb1-a8e3-dcac43b840cf | 2026-09-01 | Warnings, Adverse reactions | 197361 308135 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | NCS HealthCare of KY, LLC dba Vangard Labs | 6efc0ef6-0424-44fc-a9ea-eb30c3b83239 | 2026-09-01 | Warnings, Adverse reactions | 197361 308136 308135 864V2Q084H |
| olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide | OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 57ffeef7-bfa8-4f92-aadc-23cd00022607 | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | QPharma, Inc. | 5866d1ee-631d-d09e-e063-6294a90abe01 | 2026-08-20 | Warnings, Adverse reactions | 197361 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | American Health Packaging | 79f41cd2-6d58-4b03-8b0c-ca91398bc1a9 | 2026-08-17 | Warnings, Adverse reactions | 197361 308135 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Redpharm Drug | 58d2fbed-3904-3e31-e063-6294a90af21d | 2026-08-12 | Warnings, Adverse reactions | 197361 864V2Q084H |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Redpharm Drug | 58336a97-807a-2859-e063-6294a90ad338 | 2026-08-04 | Warnings, Adverse reactions | 308135 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 58a67272-c4c7-4e2c-85a5-9d39034d12c3 | 2026-07-27 | Warnings, Adverse reactions | 308135 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Major Pharmaceuticals | edf9b22c-e37e-4b4e-8a64-20bb036c7d2d | 2026-07-27 | Warnings, Adverse reactions | 197361 308136 308135 864V2Q084H |
| AMLODIPINE BESYLATE 2.5 mg | AMLODIPINE BESYLATE | PD-Rx Pharmaceuticals, Inc. | 1080fcea-a5da-499d-a855-690c13559071 | 2026-07-17 | Warnings, Adverse reactions | ANDA078414 197361 308136 308135 864V2Q084H |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | NuCare Pharmaceuticals, Inc. | 4926f00c-ee19-3e10-e054-00144ff88e88 | 2026-07-17 | Warnings, Adverse reactions | 308135 864V2Q084H |
| Amlodipine Besylate | AMLODIPINE BESYLATE | REMEDYREPACK INC. | 4ad016ec-e158-4325-9f45-4460cf78dd98 | 2026-07-16 | Warnings, Adverse reactions | 308136 864V2Q084H |
| WIDAPLIK | TELMISARTAN, AMLODIPINE AND INDAPAMIDE | Azurity Pharmaceuticals, Inc. | a30ff81d-420b-40ea-83d8-670260a93fff | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | REMEDYREPACK INC. | d09173a1-5e3c-4c86-8c7c-15238925ef50 | 2026-07-01 | Warnings, Adverse reactions | 197361 864V2Q084H |
| Amlodipine and Benazepril Hydrochloride | AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 27b0c628-820a-48bf-a411-86c0ebd4cc8d | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 864V2Q084H |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.