Home NDC 42806-723-60 Celecoxib
Product NDC 42806-723
Requested package NDC 42806-723-60
11-digit product format 428060723
Labeler code 42806
Product ID 42806-723_2b20721c-b138-1932-e063-6394a90ae66e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler EPIC PHARMA, LLC
Application ANDA207872
Marketing category ANDA
Marketing start 2020-10-16
Substance CELECOXIB
Active strength 400 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 42806-723 42806-723-60 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207872-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 A207872-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 A207872-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 A207872-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 · 148 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 2026-02-19 14:30 UTC 2026-02 A207872-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207872-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207872-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207872-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207872-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207872-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207872-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207872-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207872-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207872-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207872-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207872-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207872-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207872-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207872-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207872-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207872-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207872-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207872-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207872-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207872-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207872-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207872-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207872-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207872-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207872-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207872-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207872-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207872-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207872-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207872-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207872-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207872-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207872-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207872-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207872-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207872-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207872-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207872-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207872-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-02-25 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 148 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Celecoxib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CELECOXIB 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JCX84Q7J1L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205322 Internal RxNorm lookup 205323 Internal RxNorm lookup 349514 Internal RxNorm lookup 686379 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42806-723-60 Celecoxib 60 in 1 BOTTLE CAPSULE 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-723 CELECOXIB (CELECOXIB) CAPSULE [EPIC PHARMA, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20250109_ac670924-0a3f-4f94-ac01-9e3c3071c990.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 · 2 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 42806-723-60 42806072360 60 CAPSULE in 1 BOTTLE (42806-723-60) 60 capsule 2020-10-16 0000-00-00 No No Current