Home NDC 71335-3075-2 Naproxen Sodium
Product NDC 71335-3075
Requested package NDC 71335-3075-2
11-digit product format 713353075
Labeler code 71335
Product ID 71335-3075_405bbf1d-085e-461b-9b57-102cafa88a4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA078314
Marketing category ANDA
Marketing start 2007-08-01
Substance NAPROXEN SODIUM
Active strength 550 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 86 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 2026-09-14 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…2019-12-13 00:20 UTC 2019-12 A078314-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2007-04-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078314-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2007-04-27 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Naproxen Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPROXEN SODIUM 550 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9TN87S3A3C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849431 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# 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 ndc (package): 71335-3075-2 ndc (product): 71335-3075 ndc11 (package): 71335307502 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 Units Marketing start Sample Exclude flag Status 71335-3075-2 71335307502 100 TABLET in 1 BOTTLE (71335-3075-2) 100 tablet 2026-02-09 No No Current