Home NDC 0093-7166 Celecoxib
Product NDC 0093-7166
11-digit product format 000937166
Labeler code 0093
Product ID 0093-7166_6fff9b26-6a00-4968-b7c8-d7b33f6915f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA076898
Marketing category ANDA
Marketing start 2014-12-10
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A076898-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 A076898-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 A076898-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 A076898-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30
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 2026-10-15 13:18:30 2026-09 A076898-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076898-002 CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076898-003 CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076898-004 CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076898-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076898-002 CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076898-003 CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076898-004 CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076898-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076898-002 CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076898-003 CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076898-004 CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076898-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076898-002 CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076898-003 CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076898-004 CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076898-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076898-002 CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076898-003 CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076898-004 CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076898-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076898-002 CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076898-003 CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076898-004 CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076898-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076898-002 CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076898-003 CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076898-004 CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076898-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076898-002 CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076898-003 CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076898-004 CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076898-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076898-002 CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076898-003 CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076898-004 CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076898-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076898-002 CELECOXIB 100MG CAPSULE / ORAL AB 2014-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076898-003 CELECOXIB 200MG CAPSULE / ORAL AB 2014-05-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076898-004 CELECOXIB 400MG CAPSULE / ORAL AB 2014-05-30 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 5 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0093-7166-01 00093716601 100 CAPSULE in 1 BOTTLE (0093-7166-01) 100 capsule 2014-12-10 0000-00-00 No No Current 0093-7166-05 00093716605 500 CAPSULE in 1 BOTTLE (0093-7166-05) 500 capsule 2014-12-10 0000-00-00 No No Current