Home NDC 63187-535 Naproxen
Product NDC 63187-535
11-digit product format 631870535
Labeler code 63187
Product ID 63187-535_bd0691c5-aaa9-472e-9b05-926d93defd0c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA078250
Marketing category ANDA
Marketing start 2007-07-01
Substance NAPROXEN
Active strength 375 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 375 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 198012 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-535 NAPROXEN TABLET [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 6 package rows 20210114_3e4e5371-d796-47c7-95c1-d99e82a0b282.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 Marketing end Sample Exclude flag Status 63187-535-15 63187053515 15 TABLET in 1 BOTTLE (63187-535-15) 15 tablet 2018-12-01 0000-00-00 No No Current 63187-535-20 63187053520 20 TABLET in 1 BOTTLE (63187-535-20) 20 tablet 2018-12-01 0000-00-00 No No Current 63187-535-30 63187053530 30 TABLET in 1 BOTTLE (63187-535-30) 30 tablet 2018-12-01 0000-00-00 No No Current 63187-535-45 63187053545 45 TABLET in 1 BOTTLE (63187-535-45) 45 tablet 2018-12-01 0000-00-00 No No Current 63187-535-60 63187053560 60 TABLET in 1 BOTTLE (63187-535-60) 60 tablet 2018-12-01 0000-00-00 No No Current 63187-535-90 63187053590 90 TABLET in 1 BOTTLE (63187-535-90) 90 tablet 2018-12-01 0000-00-00 No No Current