Home NDC 68788-8797 Naproxen
Product NDC 68788-8797
11-digit product format 687888797
Labeler code 68788
Product ID 68788-8797_9ad5813d-635f-4829-9e46-7cf61c64238f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA078250
Marketing category ANDA
Marketing start 2025-01-01
Substance NAPROXEN
Active strength 500 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078250-001 NAPROXEN NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 A078250-002 NAPROXEN NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 A078250-003 NAPROXEN NAPROXEN 500MG TABLET / ORAL AB 2007-03-28
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 · 132 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 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
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 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57Y76R9ATQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198014 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8797 NAPROXEN TABLET [PREFERRED PHARMACEUTICALS INC.] 1 Current NDC, 9 package rows 20250101_87acd650-ea8a-4396-be72-5568c4b1755c.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 · 23 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 68788-8797-1 68788879701 100 TABLET in 1 BOTTLE (68788-8797-1) 100 tablet 2025-01-01 No No Current 68788-8797-2 68788879702 20 TABLET in 1 BOTTLE (68788-8797-2) 20 tablet 2025-01-01 No No Current 68788-8797-3 68788879703 30 TABLET in 1 BOTTLE (68788-8797-3) 30 tablet 2025-01-01 No No Current 68788-8797-4 68788879704 40 TABLET in 1 BOTTLE (68788-8797-4) 40 tablet 2025-01-01 No No Current 68788-8797-5 68788879705 15 TABLET in 1 BOTTLE (68788-8797-5) 15 tablet 2025-01-01 No No Current 68788-8797-6 68788879706 60 TABLET in 1 BOTTLE (68788-8797-6) 60 tablet 2025-01-01 No No Current 68788-8797-7 68788879707 14 TABLET in 1 BOTTLE (68788-8797-7) 14 tablet 2025-01-01 No No Current 68788-8797-8 68788879708 120 TABLET in 1 BOTTLE (68788-8797-8) 120 tablet 2025-01-01 No No Current 68788-8797-9 68788879709 90 TABLET in 1 BOTTLE (68788-8797-9) 90 tablet 2025-01-01 No No Current