Home NDC 0054-3630 Naproxen
Product NDC 0054-3630
11-digit product format 000543630
Labeler code 0054
Product ID 0054-3630_ce07dc5c-441e-4f1c-a940-077306017c43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form SUSPENSION
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA074190
Marketing category ANDA
Marketing start 2021-02-24
Substance NAPROXEN
Active strength 125 mg/5mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074190-001 NAPROXEN NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074190-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074190-001 NAPROXEN 25MG/ML SUSPENSION / ORAL AB RS 1994-03-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Naproxen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN 125 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57Y76R9ATQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311913 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0054-3630-63 Naproxen 500 mL in 1 BOTTLE, PLASTIC SUSPENSION 500 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3630 NAPROXEN SUSPENSION [HIKMA PHARMACEUTICALS USA INC.] 11 Current NDC, Legacy NDC, 1 package rows 20250221_a5757b1a-62c9-4421-9794-6fb121ce9b7e.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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen NAPROXEN Hikma Pharmaceuticals USA Inc. a5757b1a-62c9-4421-9794-6fb121ce9b7e 2024-12-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 074190 application number: ANDA074190 ndc (product): 0054-3630
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-3630-63 00054363063 500 mL in 1 BOTTLE, PLASTIC (0054-3630-63) 500 ml 2021-02-24 0000-00-00 No No Current