Home NDC 72189-360 Celecoxib
Product NDC 72189-360
11-digit product format 721890360
Labeler code 72189
Product ID 72189-360_5a0b313a-2ab3-0d47-e063-6394a90ad440
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler DirectRx
Application ANDA205129
Marketing category ANDA
Marketing start 2022-06-08
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 2027-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A205129-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 A205129-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 A205129-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 A205129-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03
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 · 152 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 A205129-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205129-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205129-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205129-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205129-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205129-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205129-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205129-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205129-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205129-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205129-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205129-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205129-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205129-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205129-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205129-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205129-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205129-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205129-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205129-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205129-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205129-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205129-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205129-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205129-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205129-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205129-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205129-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205129-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205129-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205129-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205129-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205129-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205129-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205129-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205129-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205129-001 CELECOXIB 50MG CAPSULE / ORAL AB 2020-12-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205129-002 CELECOXIB 100MG CAPSULE / ORAL AB 2020-12-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205129-003 CELECOXIB 200MG CAPSULE / ORAL AB 2020-12-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205129-004 CELECOXIB 400MG CAPSULE / ORAL AB 2020-12-03 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 152 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 Celecoxib
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205323 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-360 CELECOXIB CAPSULE [DIRECTRX] 2 Current NDC, Legacy NDC, 5 package rows 20250123_e0f3aacf-df5d-dad7-e053-2995a90ac5eb.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 · 24 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Celecoxib CELECOXIB Medsource Pharmaceuticals 14962aef-7609-b29a-e063-6394a90a5399 2024-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205129 application number: ANDA205129 Celecoxib CELECOXIB Bryant Ranch Prepack 631154cd-8f61-41b2-a686-80edc711cdaa 2024-02-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205129 application number: ANDA205129 Celecoxib CELECOXIB Proficient Rx LP b9a7f32c-8136-4f29-be6b-4d5e904ca0f1 2023-05-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205129 application number: ANDA205129 Celecoxib CELECOXIB Aphena Pharma Solutions - Tennessee, LLC d258e065-e9a6-44e2-89c9-6892d771d9d3 2021-08-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 205129 application number: ANDA205129
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 72189-360-10 72189036010 10 CAPSULE in 1 BOTTLE (72189-360-10) 10 capsule 2022-06-08 0000-00-00 No No Current 72189-360-30 72189036030 30 CAPSULE in 1 BOTTLE (72189-360-30) 30 capsule 2022-06-08 0000-00-00 No No Current 72189-360-42 72189036042 42 CAPSULE in 1 BOTTLE (72189-360-42) 42 capsule 2022-06-08 0000-00-00 No No Current 72189-360-60 72189036060 60 CAPSULE in 1 BOTTLE (72189-360-60) 60 capsule 2022-06-08 0000-00-00 No No Current 72189-360-72 72189036072 120 CAPSULE in 1 BOTTLE (72189-360-72) 120 capsule 2022-06-08 No No Current 72189-360-90 72189036090 90 CAPSULE in 1 BOTTLE (72189-360-90) 90 capsule 2022-06-08 0000-00-00 No No Current