Home NDC 21130-061 Naproxen Sodium
Product NDC 21130-061
11-digit product format 211300061
Labeler code 21130
Product ID 21130-061_4650be91-1c5a-c650-e063-6394a90a4178
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler Safeway, Inc
Application ANDA091353
Marketing category ANDA
Marketing start 2023-09-30
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 1 .
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 A091353-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091353-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-09-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091353-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2011-09-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 cb3db0bc1861…
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 21130-061-05 Naproxen Sodium 50 in 1 BOTTLE TABLET 50 5 21130-061-09 Naproxen Sodium 90 in 1 BOTTLE TABLET 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21130-061 NAPROXEN SODIUM TABLET [SAFEWAY, INC] 4 Current NDC, 2 package rows 20241212_f2a297c2-3898-5e47-e053-2995a90ab3cc.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 · 14 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 21130-061-05 21130006105 50 TABLET in 1 BOTTLE (21130-061-05) 50 tablet 2023-09-30 No No Current 21130-061-09 21130006109 90 TABLET in 1 BOTTLE (21130-061-09) 90 tablet 2023-09-30 No No Current