Home NDC 13668-307 celecoxib
Product NDC 13668-307
11-digit product format 136680307
Labeler code 13668
Product ID 13668-307_bff3a32b-43e3-46cd-b5c3-b691617fe4fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA207677
Marketing category ANDA
Marketing start 2015-12-23
Substance CELECOXIB
Active strength 50 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 A207677-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 A207677-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 A207677-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 A207677-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23
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 A207677-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207677-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207677-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207677-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207677-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207677-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207677-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207677-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207677-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207677-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207677-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207677-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207677-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207677-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207677-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207677-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207677-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207677-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207677-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207677-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207677-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207677-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207677-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207677-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207677-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207677-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207677-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207677-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207677-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207677-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207677-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207677-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207677-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207677-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207677-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207677-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207677-001 CELECOXIB 50MG CAPSULE / ORAL AB 2015-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207677-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207677-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207677-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-12-23 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 50 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-307 CELECOXIB CAPSULE [TORRENT PHARMACEUTICALS LIMITED] 13 Current NDC, Legacy NDC, 7 package rows 20241226_862698b6-2cc9-4374-992d-024beae6eba3.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 · 1 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 13668-307-01 13668030701 100 CAPSULE in 1 BOTTLE (13668-307-01) 100 capsule 2015-12-23 0000-00-00 No No Current 13668-307-05 13668030705 500 CAPSULE in 1 BOTTLE (13668-307-05) 500 capsule 2015-12-23 0000-00-00 No No Current 13668-307-10 13668030710 1000 CAPSULE in 1 BOTTLE (13668-307-10) 1000 capsule 2015-12-23 0000-00-00 No No Current 13668-307-30 13668030730 30 CAPSULE in 1 BOTTLE (13668-307-30) 30 capsule 2015-12-23 0000-00-00 No No Current 13668-307-31 13668030731 2500 CAPSULE in 1 BOTTLE (13668-307-31) 2500 capsule 2015-12-23 0000-00-00 No No Current 13668-307-60 13668030760 60 CAPSULE in 1 BOTTLE (13668-307-60) 60 capsule 2015-12-23 0000-00-00 No No Current 13668-307-74 13668030774 100 CAPSULE in 1 CARTON (13668-307-74) 100 capsule 2015-12-23 0000-00-00 No No Current 13668-307-90 13668030790 90 CAPSULE in 1 BOTTLE (13668-307-90) 90 capsule 2015-12-23 0000-00-00 No No Current