Home NDC 63874-489 Naproxen Sodium
Product NDC 63874-489
11-digit product format 638740489
Labeler code 63874
Product ID 63874-489_feb7a143-ac2f-48fd-a2d1-1475337efacf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler Altura Pharmaceuticals, Inc.
Application ANDA078314
Marketing category ANDA
Marketing start 2010-01-01
Marketing end 0000-00-00
Substance NAPROXEN SODIUM
Active strength 275 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 110 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078314-001 NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 A078314-002 NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 88 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 2026-10-15 13:18:30 2026-09 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63874-489-01 Naproxen Sodium 100 in 1 BOTTLE, PLASTIC TABLET 100 1 63874-489-30 Naproxen Sodium 30 in 1 BOTTLE, PLASTIC TABLET 30 1 63874-489-60 Naproxen Sodium 60 in 1 BOTTLE, PLASTIC TABLET 60 1 63874-489-90 Naproxen Sodium 90 in 1 BOTTLE, PLASTIC TABLET 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN ACTIVE INGREDIENT 57Y76R9ATQ NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63874-489 NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 Legacy NDC, 4 package rows 20100430_4bbe6e74-b13e-4609-b4cc-aa0b00d66df8.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen Sodium NAPROXEN SODIUM Advanced Rx of Tennessee, LLC 36996557-3227-b753-e063-6394a90a7b6f 2026-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078314 application number: ANDA078314 Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack 83dd8829-7ba0-4a8d-a979-41a5e077c49f 2026-02-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078314 application number: ANDA078314 Naproxen Sodium NAPROXEN SODIUM Glenmark Pharmaceuticals Inc., USA 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9 2025-12-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078314 application number: ANDA078314
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 63874-489-01 63874048901 100 in 1 BOTTLE, PLASTIC Historical 63874-489-30 63874048930 30 in 1 BOTTLE, PLASTIC Historical 63874-489-60 63874048960 60 in 1 BOTTLE, PLASTIC Historical 63874-489-90 63874048990 90 in 1 BOTTLE, PLASTIC Historical