Home NDC 42192-619 Naproxen
Product NDC 42192-619
11-digit product format 421920619
Labeler code 42192
Product ID 42192-619_47a98b71-a338-b13d-e063-6394a90a96f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form SUSPENSION
Route ORAL
Labeler Acella Pharmaceuticals, LLC
Application NDA018965
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2020-11-12
Marketing end 2028-01-31
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
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 N018965-001 NAPROSYN NAPROXEN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018965-001 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 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018965-001 NAPROSYN 25MG/ML SUSPENSION / ORAL AB RLD 1987-03-23 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 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 42192-619-16 Naproxen 473 mL in 1 BOTTLE SUSPENSION 473 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42192-619 NAPROXEN SUSPENSION [ACELLA PHARMACEUTICALS, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20230118_7e6f03fb-4b36-4418-9684-f45637abbb78.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 Acella Pharmaceuticals, LLC 7e6f03fb-4b36-4418-9684-f45637abbb78 2026-01-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018965 application number: NDA018965 ndc (product): 42192-619
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 42192-619-16 42192061916 473 mL in 1 BOTTLE (42192-619-16) 473 ml 2020-11-12 2028-01-31 No No Current