Home NDC 62135-176 OXAPROZIN
Product NDC 62135-176
11-digit product format 621350176
Labeler code 62135
Product ID 62135-176_2526421a-bb2b-1e0b-e063-6394a90a42fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name OXAPROZIN
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC.
Application ANDA075987
Marketing category ANDA
Marketing start 2004-09-02
Substance OXAPROZIN
Active strength 600 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A075987-001 OXAPROZIN OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075987-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075987-001 OXAPROZIN 600MG TABLET / ORAL AB 2004-09-02 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base OXAPROZIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXAPROZIN 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MHJ80W9LRB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312132 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 62135-176-18 OXAPROZIN 180 in 1 BOTTLE TABLET 180 4 62135-176-60 OXAPROZIN 60 in 1 BOTTLE TABLET 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-176 OXAPROZIN TABLET [CHARTWELL RX, LLC.] 4 Current NDC, Legacy NDC, 2 package rows 20241025_db349233-9f09-471c-aeee-f91338d2ffe9.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 · 1 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 62135-176-18 62135017618 180 TABLET in 1 BOTTLE (62135-176-18) 180 tablet 2022-08-22 0000-00-00 No No Current 62135-176-60 62135017660 60 TABLET in 1 BOTTLE (62135-176-60) 60 tablet 2022-08-22 0000-00-00 No No Current