Home NDC 65862-909 Celecoxib
Product NDC 65862-909
11-digit product format 658620909
Labeler code 65862
Product ID 65862-909_5969bc02-84f8-41e5-a6b5-abcb6a985591
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA206827
Marketing category ANDA
Marketing start 2016-02-01
Substance CELECOXIB
Active strength 200 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206827-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 A206827-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 A206827-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 A206827-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01
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 5 · 168 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 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206827-001 CELECOXIB 50MG CAPSULE / ORAL AB 2016-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206827-002 CELECOXIB 100MG CAPSULE / ORAL AB 2016-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206827-003 CELECOXIB 200MG CAPSULE / ORAL AB 2016-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206827-004 CELECOXIB 400MG CAPSULE / ORAL AB 2016-02-01 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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 200 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-909-01 Celecoxib 100 in 1 BOTTLE CAPSULE 100 9 65862-909-05 Celecoxib 500 in 1 BOTTLE CAPSULE 500 9 65862-909-99 Celecoxib 1000 in 1 BOTTLE CAPSULE 1000 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-909 CELECOXIB CAPSULE [AUROBINDO PHARMA LIMITED] 9 Current NDC, Legacy NDC, 3 package rows 20241215_1e811c3a-5653-4617-b958-380802cc443a.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 · 3 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 65862-909-01 65862090901 100 CAPSULE in 1 BOTTLE (65862-909-01) 100 capsule 2016-02-01 0000-00-00 No No Current 65862-909-05 65862090905 500 CAPSULE in 1 BOTTLE (65862-909-05) 500 capsule 2016-02-01 0000-00-00 No No Current 65862-909-99 65862090999 1000 CAPSULE in 1 BOTTLE (65862-909-99) 1000 capsule 2016-02-01 0000-00-00 No No Current