Home NDC 68462-188 Naproxen
Product NDC 68462-188
11-digit product format 684620188
Labeler code 68462
Product ID 68462-188_16372549-a419-4920-a200-5128017570ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naproxen
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA078250
Marketing category ANDA
Marketing start 2007-07-01
Substance NAPROXEN
Active strength 250 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 43 .
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 · 129 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 2026-09-14 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078250-002 NAPROXEN 375MG TABLET / ORAL AB 2007-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078250-003 NAPROXEN 500MG TABLET / ORAL AB 2007-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078250-001 NAPROXEN 250MG TABLET / ORAL AB 2007-03-28 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57Y76R9ATQ Internal UNII lookup 9TN87S3A3C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198012 Internal RxNorm lookup 198013 Internal RxNorm lookup 198014 Internal RxNorm lookup 849398 Internal RxNorm lookup 849431 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 68462-188-01 Naproxen 100 in 1 BOTTLE TABLET 100 13 68462-188-05 Naproxen 500 in 1 BOTTLE TABLET 500 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAPROXEN ACTIVE INGREDIENT 57Y76R9ATQ NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 NAPROXEN ACTIVE INGREDIENT 57Y76R9ATQ NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 NAPROXEN ACTIVE INGREDIENT 57Y76R9ATQ NAPROXEN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC] 1 NAPROXEN ACTIVE INGREDIENT 57Y76R9ATQ NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS] 1 NAPROXEN ACTIVE INGREDIENT 57Y76R9ATQ NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 NAPROXEN ACTIVE INGREDIENT 57Y76R9ATQ NAPROXEN TABLET [REBEL DISTRIBUTORS CORP] 1 NAPROXEN ACTIVE INGREDIENT 57Y76R9ATQ NAPROXEN TABLET [PROFICIENT RX LP] 1 NAPROXEN SODIUM ACTIVE INGREDIENT 9TN87S3A3C NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN TABLET [REBEL DISTRIBUTORS CORP] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN TABLET [PROFICIENT RX LP] 1 NAPROXEN ACTIVE MOIETY 57Y76R9ATQ NAPROXEN SODIUM TABLET [NORTHWIND PHARMACEUTICALS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN TABLET [PROFICIENT RX LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN TABLET [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NAPROXEN TABLET [REBEL DISTRIBUTORS CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NAPROXEN TABLET [PROFICIENT RX LP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NAPROXEN TABLET [PROFICIENT RX LP] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT NAPROXEN TABLET [PROFICIENT RX LP] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN TABLET [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN TABLET [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E NAPROXEN TABLET [REBEL DISTRIBUTORS CORP] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E NAPROXEN TABLET [CONTRACT PHARMACY SERVICES-PA] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E NAPROXEN TABLET [PROFICIENT RX LP] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U NAPROXEN TABLET NAPROXEN SODIUM TABLET [ALTURA PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-188 NAPROXEN TABLET NAPROXEN SODIUM TABLET [GLENMARK PHARMACEUTICALS INC., USA] 12 Current NDC, Legacy NDC, 2 package rows 20240814_6c5bb008-e66f-4ef0-bf84-aca7eb5983e9.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 68462-188-01 68462018801 100 TABLET in 1 BOTTLE (68462-188-01) 100 tablet 2007-07-01 0000-00-00 No No Current 68462-188-05 68462018805 500 TABLET in 1 BOTTLE (68462-188-05) 500 tablet 2007-07-01 0000-00-00 No No Current