Home NDC 71335-0822 Naproxen Sodium
Product NDC 71335-0822
11-digit product format 713350822
Labeler code 71335
Product ID 71335-0822_25e161db-5f02-4458-bec7-b5a99f425a19
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA200629
Marketing category ANDA
Marketing start 2011-10-31
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 2026-12-31
Current FDA listing Yes 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 1 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A200629-001 NAPROXEN SODIUM NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 A200629-002 NAPROXEN SODIUM NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31
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 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200629-001 NAPROXEN SODIUM EQ 250MG BASE TABLET / ORAL AB 2011-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200629-002 NAPROXEN SODIUM EQ 500MG BASE TABLET / ORAL AB 2011-10-31 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 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 71335-0822-0 2024-05-16 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-1 2024-05-16 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-2 2024-05-16 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-3 2024-05-16 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-4 2024-05-16 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-5 2024-05-16 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-6 2024-05-16 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-7 2024-05-16 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-8 2024-05-16 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-9 2024-05-16 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-0 2024-01-30 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-1 2024-01-30 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-2 2024-01-30 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-3 2024-01-30 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-4 2024-01-30 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-5 2024-01-30 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-6 2024-01-30 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-7 2024-01-30 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-8 2024-01-30 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976 71335-0822-9 2024-01-30 These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-0822-0 Naproxen Sodium 6 in 1 BOTTLE TABLET, FILM COATED 6 8 71335-0822-1 Naproxen Sodium 20 in 1 BOTTLE TABLET, FILM COATED 20 8 71335-0822-2 Naproxen Sodium 100 in 1 BOTTLE TABLET, FILM COATED 100 8 71335-0822-3 Naproxen Sodium 30 in 1 BOTTLE TABLET, FILM COATED 30 8 71335-0822-4 Naproxen Sodium 120 in 1 BOTTLE TABLET, FILM COATED 120 8 71335-0822-5 Naproxen Sodium 60 in 1 BOTTLE TABLET, FILM COATED 60 8 71335-0822-6 Naproxen Sodium 90 in 1 BOTTLE TABLET, FILM COATED 90 8 71335-0822-7 Naproxen Sodium 42 in 1 BOTTLE TABLET, FILM COATED 42 8 71335-0822-8 Naproxen Sodium 14 in 1 BOTTLE TABLET, FILM COATED 14 8 71335-0822-9 Naproxen Sodium 56 in 1 BOTTLE TABLET, FILM COATED 56 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0822 NAPROXEN SODIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 7 Current NDC, Legacy NDC, 10 package rows 20250221_0e7697ad-25c6-4405-9f9b-791633cb1ef7.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack 1c2325f7-1d65-429d-a64d-6ab075df1c20 2026-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200629 application number: ANDA200629 Naproxen Sodium NAPROXEN SODIUM Bryant Ranch Prepack 0e7697ad-25c6-4405-9f9b-791633cb1ef7 2025-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200629 application number: ANDA200629 ndc (product): 71335-0822 Naproxen Sodium NAPROXEN SODIUM Aurobindo Pharma Limited 37b264f9-b46d-4635-8fab-246b1e08b653 2025-09-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200629 application number: ANDA200629 Naproxen Sodium NAPROXEN SODIUM Proficient Rx LP 397db794-027c-4a89-993e-07c208b457a3 2020-09-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200629 application number: ANDA200629
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71335-0822-0 71335082200 6 TABLET, FILM COATED in 1 BOTTLE (71335-0822-0) 2025-01-29 0000-00-00 No No Current 71335-0822-1 71335082201 20 TABLET, FILM COATED in 1 BOTTLE (71335-0822-1) 2020-02-21 0000-00-00 No No Current 71335-0822-2 71335082202 100 TABLET, FILM COATED in 1 BOTTLE (71335-0822-2) 2025-01-29 0000-00-00 No No Current 71335-0822-3 71335082203 30 TABLET, FILM COATED in 1 BOTTLE (71335-0822-3) 2018-08-23 0000-00-00 No No Current 71335-0822-4 71335082204 120 TABLET, FILM COATED in 1 BOTTLE (71335-0822-4) 2018-05-29 0000-00-00 No No Current 71335-0822-5 71335082205 60 TABLET, FILM COATED in 1 BOTTLE (71335-0822-5) 2018-04-26 0000-00-00 No No Current 71335-0822-6 71335082206 90 TABLET, FILM COATED in 1 BOTTLE (71335-0822-6) 2025-01-29 0000-00-00 No No Current 71335-0822-7 71335082207 42 TABLET, FILM COATED in 1 BOTTLE (71335-0822-7) 2025-01-29 0000-00-00 No No Current 71335-0822-8 71335082208 14 TABLET, FILM COATED in 1 BOTTLE (71335-0822-8) 2025-01-29 0000-00-00 No No Current 71335-0822-9 71335082209 56 TABLET, FILM COATED in 1 BOTTLE (71335-0822-9) 2025-01-29 0000-00-00 No No Current