Home NDC 81522-045 Naproxen Sodium
Product NDC 81522-045
11-digit product format 815220045
Labeler code 81522
Product ID 81522-045_37cb3db7-1ced-fafb-e063-6394a90a8f39
Type HUMAN OTC DRUG
Nonproprietary name NAPROXEN SODIUM
Dosage form TABLET, COATED
Route ORAL
Labeler FSA STORE INC.
Application ANDA079096
Marketing category ANDA
Marketing start 2023-05-02
Substance NAPROXEN SODIUM
Active strength 220 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A079096-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16
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 · 43 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 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079096-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2008-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079096-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2008-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079096-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2008-12-16 f41ea6bd6efb…
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 220 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 849574 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 81522-045-05 Naproxen Sodium 1 in 1 CARTON TABLET, COATED 1 3 81522-045-05 Naproxen Sodium 200 in 1 BOTTLE, PLASTIC TABLET, COATED 200 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81522-045 NAPROXEN SODIUM TABLET, COATED [FSA STORE INC.] 2 Current NDC, 2 package rows 20230504_f4326f99-142b-0b70-e053-2995a90ac951.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 2 of 2 · 31 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 81522-045-05 81522004505 1 BOTTLE, PLASTIC in 1 CARTON (81522-045-05) / 200 TABLET, COATED in 1 BOTTLE, PLASTIC 2023-05-02 No No Current