NDC 57664-569 - Amlodipine
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
- 57664-569
- Package NDCs from labels
- 57664-569-99, 57664-569-88, 57664-569-13, 57664-569-18
- Manufacturer
- CARACO PHARMACEUTICAL LABORATORIES, LTD.
- Effective date
- 2008-12-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Amlodipine - CARACO PHARMACEUTICAL LABORATORIES, LTD. | CARACO PHARMACEUTICAL LABORATORIES, LTD. | 2008-12-15 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57664-569-13 | Amlodipine | 500 in 1 BOTTLE | TABLET | 500 | 1 | |
| 57664-569-18 | Amlodipine | 1000 in 1 BOTTLE | TABLET | 1000 | 1 | |
| 57664-569-88 | Amlodipine | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 57664-569-99 | Amlodipine | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57664-569-13 | EA - Each | 57664-569 | 16785f0f-d993-40b4-86a5-5ada750be530 | 1 | 2013-02-13 |
| 57664-569-18 | EA - Each | 57664-569 | 5df3b1d9-e39c-4fb8-af53-d9f8d8a869a4 | 1 | 2013-02-13 |
| 57664-569-99 | EA - Each | 57664-569 | a04536fe-5362-4bc9-b359-6b1d07454578 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Amlodipine besylate | ACTIVE INGREDIENT | 864V2Q084H | AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | |
| Amlodipine | ACTIVE MOIETY | 1J444QC288 | AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | |
| butylated hydroxytoluene | INACTIVE INGREDIENT | 1P9D0Z171K | AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | |
| dibasic calcium phosphate | INACTIVE INGREDIENT | AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | ||
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | |
| microcrystalline cellulose | INACTIVE INGREDIENT | OP1R32D61U | AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 1 | |
| sodium starch glycolate | INACTIVE INGREDIENT | AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 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 | AMLODIPINE BESYLATE | Bryant Ranch Prepack | 498a9b21-34b9-4373-930b-5ed43201a345 | 2024-01-09 | Warnings, Adverse reactions | 308136 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Bryant Ranch Prepack | e8958997-f098-44ce-8c21-b7064d1a962e | 2024-01-09 | Warnings, Adverse reactions | 197361 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 5c50c3fe-afe5-459e-95c0-c9af4cbb6909 | 2023-11-13 | Warnings, Adverse reactions | 308135 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | A-S Medication Solutions | 4512feee-a09d-4244-bc03-c43193e53a0e | 2023-09-20 | Warnings, Adverse reactions | 197361 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | d830173d-7676-4490-ab3d-d3515df9ad2e | 2023-09-07 | Warnings, Adverse reactions | 308136 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee1 | 2023-09-07 | Warnings, Adverse reactions | 197361 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | ced6d26e-8c54-4808-88b6-446344f4acd0 | 2023-06-01 | Warnings, Adverse reactions | 308136 |
| AMLODIPINE BESYLATE | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | 186b6149-9610-4380-9bf2-941646069276 | 2023-05-04 | Warnings, Adverse reactions | 197361 |
| AMLODIPINE BESYLATE 5 mg | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | b597d1e1-aba1-4272-bed7-4c95e8150d58 | 2023-04-19 | Warnings, Adverse reactions | 197361 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Exelan Pharmaceuticals, Inc. | efd9eda5-f497-45a3-ae13-dee729add999 | 2023-03-23 | Warnings, Adverse reactions | 197361 308136 308135 |
| Norvasc | AMLODIPINE BESYLATE | Viatris Specialty LLC | 7367289c-b0b0-466a-83e2-558e2985c29f | 2023-02-15 | Warnings, Adverse reactions | 197361 308136 308135 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Unichem Pharmaceuticals (USA), Inc. | a516b336-8f60-4b86-8921-c7d6c07629f2 | 2022-12-05 | Warnings, Adverse reactions | 197361 308136 308135 |
| amlodipine besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | f3482709-c5c3-4bd0-8067-ad57f31bb525 | 2022-10-18 | Warnings, Adverse reactions | 308135 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 445d1274-7249-476b-ad90-ff93aee56f6d | 2022-06-01 | Warnings, Adverse reactions | 197361 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d6 | 2022-04-01 | Warnings, Adverse reactions | 308135 |
| Amlodipine besylate | AMLODIPINE BESYLATE | Exelan Pharmaceuticals, Inc. | 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 | 2022-03-12 | Warnings, Adverse reactions | 197361 308136 308135 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | c2c51ec3-ffb0-4240-b048-a8e424775a76 | 2021-08-01 | Warnings, Adverse reactions | 197361 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Aphena Pharma Solutions - Tennessee, LLC | afcffa7b-03b7-499a-b50c-37b0e28c7737 | 2021-05-11 | Warnings, Adverse reactions | 197361 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Proficient Rx LP | 9f327d08-7661-4088-b554-2f9a99a113e7 | 2020-10-01 | Warnings, Adverse reactions | 308135 |
| Amlodipine Besylate | AMLODIPINE BESYLATE | Cipla USA Inc. | 0c8d6b2f-3e4a-47a2-80e2-a34dcb337555 | 2020-09-09 | Warnings, Adverse reactions | 197361 308136 308135 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.