Home NDC 68788-7572 Naproxen
Product NDC 68788-7572
11-digit product format 687887572
Labeler code 68788
Product ID 68788-7572_66d9e7eb-5d77-4070-bc89-1ced4362747c
Type HUMAN OTC DRUG
Nonproprietary name Naproxen Sodium
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals, Inc.
Application ANDA204872
Marketing category ANDA
Marketing start 2019-01-01
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 A204872-001 NAPROXEN SODIUM NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23
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 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204872-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2017-01-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204872-001 NAPROXEN SODIUM EQ 200MG BASE TABLET / ORAL 2017-01-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204872-001 NAPROXEN SODIUM 220MG TABLET / ORAL 2017-01-23 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
Listing expiration 2027-12-31 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 68788-7572-2 Naproxen 20 in 1 BOTTLE TABLET 20 7 68788-7572-3 Naproxen 30 in 1 BOTTLE TABLET 30 7 68788-7572-4 Naproxen 40 in 1 BOTTLE TABLET 40 7 68788-7572-6 Naproxen 60 in 1 BOTTLE TABLET 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7572 NAPROXEN (NAPROXEN SODIUM) TABLET [PREFERRED PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20240724_20eb9d9f-11df-464f-a1b0-949f8fda4042.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 · 24 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68788-7572-2 68788757202 20 TABLET in 1 BOTTLE (68788-7572-2) 20 tablet 2019-12-27 0000-00-00 No No Current 68788-7572-3 68788757203 30 TABLET in 1 BOTTLE (68788-7572-3) 30 tablet 2019-12-27 0000-00-00 No No Current 68788-7572-4 68788757204 40 TABLET in 1 BOTTLE (68788-7572-4) 40 tablet 2019-12-27 0000-00-00 No No Current 68788-7572-6 68788757206 60 TABLET in 1 BOTTLE (68788-7572-6) 60 tablet 2019-12-27 0000-00-00 No No Current