Home NDC 37835-594 Naproxen Sodium
Product NDC 37835-594
11-digit product format 378350594
Labeler code 37835
Product ID 37835-594_5ee9c6b5-c3cc-6695-e063-6394a90aac5d
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler Bi-Mart
Application ANDA091353
Marketing category ANDA
Marketing start 2011-09-30
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091353-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2011-09-20 caaa826d4ba7…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…
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 220 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 37835-594-01 Naproxen Sodium 100 in 1 BOTTLE TABLET 100 1 37835-594-03 Naproxen Sodium 300 in 1 BOTTLE TABLET 300 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37835-594 NAPROXEN SODIUM TABLET [BI-MART] 1 Current NDC, 2 package rows 20250330_6d5cecc9-5095-477b-bfc7-45b6e7e689f0.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 · 13 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 37835-594-01 37835059401 100 TABLET in 1 BOTTLE (37835-594-01) 100 tablet 2025-03-01 No No Current 37835-594-03 37835059403 300 TABLET in 1 BOTTLE (37835-594-03) 300 tablet 2025-03-01 No No Current