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 | Asclemed USA, Inc. | 1e406e47-408a-48cc-921e-52882a11581c | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198014 57Y76R9ATQ |
| Naproxen Oral Suspension | NAPROXEN ORAL | ANI Pharmaceuticals, Inc. | 252726a7-757a-4b97-b5b8-ffff4ac1d103 | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 9d7bc470-fbba-40a6-a56c-f681a3cee9cf | 2025-03-24 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Preferred Pharmaceuticals Inc. | 727913f6-9542-4a2d-9318-4b7ff521bffd | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | Amneal Pharmaceuticals of New York LLC | 2718e0b7-1ce6-457e-bee9-11b634dfd353 | 2025-03-14 | Boxed warning, Warnings, Adverse reactions | 198014 198013 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | ANI Pharmaceuticals, Inc. | 052e6fe3-d619-42c3-b64e-67c7aaf7271c | 2025-03-12 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ScieGen Pharmaceuticals, Inc | 167340c2-1234-4d00-b4e2-cccf3d270fda | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Walgreens Soothing Eye Relief Lubricant Eye Drops | POLYVINYL ALCOHOL, POVIDONE | Walgreens Co. | 29b7387b-ad65-3a11-e063-6394a90a6a15 | 2025-02-14 | Warnings | FZ989GH94E |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | 3f1c66f0-2d9d-4be1-8656-1dbed2c9c715 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | Direct_Rx | f499a207-02c8-a338-e053-2995a90accc0 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198012 57Y76R9ATQ |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | f3a3eea2-f6b3-4559-8536-26c1125df3e1 | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| NAPROXEN | NAPROXEN | DIRECT RX | b1b78c49-82e9-2402-e053-2a95a90ae35f | 2025-01-17 | Warnings | 198014 57Y76R9ATQ |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | 19aadd4b-647b-4c75-9059-9a2c68a18561 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
| Naproxen | NAPROXEN | Advanced Rx of Tennessee, LLC | af9ad850-57b5-a21d-e053-2a95a90ae68e | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | Advanced Rx of Tennessee, LLC | af9a94a8-3825-eabd-e053-2a95a90acd58 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Advanced Rx of Tennessee, LLC | af9a96cf-1cda-8ace-e053-2a95a90a18cc | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 198012 57Y76R9ATQ |
| Naproxen | NAPROXEN | Advanced Rx of Tennessee, LLC | af9ac948-4405-5abf-e053-2995a90af2b5 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Advanced Rx of Tennessee, LLC | af9aa7a0-e287-5935-e053-2995a90a1d11 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 198014 57Y76R9ATQ |
| Naproxen | NAPROXEN | Advanced Rx Pharmacy of Tennessee, LLC | d292f376-1844-b01c-e053-2a95a90a0927 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA212517 198012 57Y76R9ATQ |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Asclemed USA, Inc. | 7b3af5a8-0c92-43f4-af13-7a47dca20e92 | 2024-12-28 | Boxed warning, Warnings, Adverse reactions | 57Y76R9ATQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.