NDC 85534-0023-01 - Naproxen
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
- 85534-0023
- Requested NDC
- 85534-0023-01
- Package NDCs from labels
- 85534-0023-0, 85534-0023-1, 85534-0023-2, 85534-0023-3, 85534-0023-01
- Manufacturer
- HAWAII REPACK, INC.
- Effective date
- 2026-06-26
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Naproxen - HAWAII REPACK, INC. | HAWAII REPACK, INC. | 2026-06-26 | HUMAN PRESCRIPTION DRUG LABEL |
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 |
|---|---|---|---|---|---|---|
| Naproxen | NAPROXEN | A-S Medication Solutions | a8b54258-84e7-41e8-9e51-137a3f442e6b | 2023-10-23 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | 80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba4 | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | 50c52976-9e04-4a5e-9f21-aca3ea5c2924 | 2023-09-06 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | d801ba16-e2ec-4bb2-8cff-32388634b35a | 2023-09-06 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | 21930f73-d3c2-4462-a487-74ed871b74b2 | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 198013 57Y76R9ATQ |
| Naproxen | NAPROXEN | A-S Medication Solutions | a5ea3a84-7acd-4f24-9f0f-9f871ce1b5f4 | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 198012 57Y76R9ATQ |
| naproxen | NAPROXEN | Cipla USA Inc. | a9549a47-3fa4-4a2b-95ac-b00e43aedae7 | 2023-01-18 | Boxed warning, Warnings, Adverse reactions | 198014 198013 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | Proficient Rx LP | d0670241-f1f9-4fdf-83d4-547e7b800811 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| NAPROXEN | NAPROXEN | Asclemed USA, Inc. | a4fcb411-c918-459b-adc6-06dfa8ed8a50 | 2022-10-12 | Warnings | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Proficient Rx LP | aa4d159c-9cbe-4d29-9532-33a312f1ae05 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 198013 57Y76R9ATQ |
| Naproxen | NAPROXEN | Proficient Rx LP | 96601d76-50ea-4dc0-b588-d174f8d8bb51 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Aphena Pharma Solutions - Tennessee, LLC | 98efdeb8-ea38-456e-953f-ba589727f284 | 2021-11-10 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Aphena Pharma Solutions - Tennessee, LLC | 9c963e77-6e05-47d0-a8d3-e581777377b9 | 2021-08-19 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198013 198012 57Y76R9ATQ |
| NAPROXEN | NAPROXEN | Aphena Pharma Solutions - Tennessee, LLC | 32693390-763b-46dd-b821-65a7bf3c6671 | 2021-04-26 | Warnings | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Proficient Rx LP | fc3ee94a-adb7-411e-a662-2f2c6ddbabaf | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Proficient Rx LP | 3e4e5371-d796-47c7-95c1-d99e82a0b282 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | Aphena Pharma Solutions - Tennessee, LLC | 3e14f839-d1e4-44df-a457-29f005b3e62e | 2020-12-15 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| NAPROXEN | NAPROXEN | Bryant Ranch Prepack | 5d399bf3-db49-411a-91b9-b410d702a65a | 2020-12-14 | Warnings | 198013 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | Exelan Pharmaceuticals, Inc. | 46dbdb95-a0d0-4410-8d64-b22763b12af7 | 2020-08-17 | Boxed warning, Warnings, Adverse reactions | 198014 198013 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | Proficient Rx LP | 69a3afd6-d64b-4f07-b848-b0d3fc19f2a2 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.