Home NDC 53808-0742 Naproxen Sodium
Product NDC 53808-0742
11-digit product format 538080742
Labeler code 53808
Product ID 53808-0742_e46640dd-311d-4e68-9424-7c4c7ade7847
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NAPROXEN SODIUM
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA074201
Marketing category ANDA
Marketing start 2009-07-01
Marketing end 0000-00-00
Substance NAPROXEN SODIUM
Active strength 550 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 2018-12-31
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 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53808-0742-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53808-0742-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53808-0742-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53808-0742-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53808-0742-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53808-0742-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-0742-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-0742-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-0742-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-0742-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-0742-1 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-0742-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-0742-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-0742-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-0742-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-0742-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-0742-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-0742-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-0742-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-0742-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-0742-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53808-0742-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074201-001 NAPROXEN NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 A074201-002 NAPROXEN NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 A074201-003 NAPROXEN NAPROXEN 500MG TABLET / ORAL AB 1993-12-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 2026-08-18 06:07:40 2026-07 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074201-002 NAPROXEN 375MG TABLET / ORAL AB 1993-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074201-003 NAPROXEN 500MG TABLET / ORAL AB 1993-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074201-001 NAPROXEN 250MG TABLET / ORAL AB 1993-12-21 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 53808-0742-1 Naproxen Sodium 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-0742 NAPROXEN SODIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20100611_5d85fd0c-c544-4026-b797-93445ce6ba7e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-0742-1 53808074201 30 in 1 BLISTER PACK Historical