Home NDC 50090-8133 Celecoxib
Product NDC 50090-8133
11-digit product format 500908133
Labeler code 50090
Product ID 50090-8133_4fc1554e-4360-499c-9196-9cbf0a95905b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA208856
Marketing category ANDA
Marketing start 2025-12-15
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 A208856-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 A208856-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 A208856-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 A208856-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07
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 · 176 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 2026-11-14 07:37:17 2026-10 A208856-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A208856-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A208856-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A208856-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A208856-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208856-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208856-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208856-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208856-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208856-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208856-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208856-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208856-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208856-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208856-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208856-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208856-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208856-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208856-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208856-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208856-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208856-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208856-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208856-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208856-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208856-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208856-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208856-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208856-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208856-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208856-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208856-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208856-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208856-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208856-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208856-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208856-001 CELECOXIB 50MG CAPSULE / ORAL AB 2019-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208856-002 CELECOXIB 100MG CAPSULE / ORAL AB 2019-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208856-003 CELECOXIB 200MG CAPSULE / ORAL AB 2019-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208856-004 CELECOXIB 400MG CAPSULE / ORAL AB 2019-08-07 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 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.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Celecoxib CELECOXIB St. Mary's Medical Park Pharmacy 59f495e8-3cea-9d98-e063-6394a90a89d4 2026-08-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208856 application number: ANDA208856 Celecoxib CELECOXIB AiPing Pharmaceutical, Inc. 89db0dec-3800-4d89-a765-24838f4d0c30 2026-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208856 application number: ANDA208856 CELECOXIB CELECOXIB Qingdao BAHEAL Pharmaceutical Co., Ltd. 87c16a33-5eb0-40b0-a020-ed924326f697 2026-01-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208856 application number: ANDA208856
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-8133-0 50090813300 30 CAPSULE in 1 BOTTLE (50090-8133-0) 30 capsule 2026-10-08 No No Current 50090-8133-1 50090813301 60 CAPSULE in 1 BOTTLE (50090-8133-1) 60 capsule 2026-10-08 No No Current 50090-8133-2 50090813302 90 CAPSULE in 1 BOTTLE (50090-8133-2) 90 capsule 2026-10-08 No No Current 50090-8133-3 50090813303 7 CAPSULE in 1 BOTTLE (50090-8133-3) 7 capsule 2026-10-08 No No Current