Home NDC 68180-395 celecoxib
Product NDC 68180-395
11-digit product format 681800395
Labeler code 68180
Product ID 68180-395_c7509f8b-4cac-4294-8e22-0e954c75f793
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA202240
Marketing category ANDA
Marketing start 2015-10-01
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 A202240-001 CELECOXIB CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 A202240-002 CELECOXIB CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 A202240-003 CELECOXIB CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 A202240-004 CELECOXIB CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09
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 A202240-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202240-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202240-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202240-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202240-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202240-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202240-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202240-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202240-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202240-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202240-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202240-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202240-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202240-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202240-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202240-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202240-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202240-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202240-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202240-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202240-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202240-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202240-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202240-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202240-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202240-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202240-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202240-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202240-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202240-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202240-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202240-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202240-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202240-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202240-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202240-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202240-001 CELECOXIB 50MG CAPSULE / ORAL AB 2014-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202240-002 CELECOXIB 100MG CAPSULE / ORAL AB 2015-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202240-003 CELECOXIB 200MG CAPSULE / ORAL AB 2015-06-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202240-004 CELECOXIB 400MG CAPSULE / ORAL AB 2015-06-09 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-395-07 celecoxib 60 in 1 BOTTLE CAPSULE 60 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CELECOXIB ACTIVE INGREDIENT JCX84Q7J1L CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 CELECOXIB ACTIVE MOIETY JCX84Q7J1L CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-395 CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 1 package rows 20231209_560017b1-daf8-464e-b86f-0a75c78002ec.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 · 2 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 68180-395-07 68180039507 60 CAPSULE in 1 BOTTLE (68180-395-07) 60 capsule 2015-10-01 0000-00-00 No No Current