Home NDC 68180-397 celecoxib
Product NDC 68180-397
11-digit product format 681800397
Labeler code 68180
Product ID 68180-397_64af7d57-a662-4efd-8180-26e3023170b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name celecoxib
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA202240
Marketing category ANDA
Marketing start 2015-08-07
Marketing end 2021-09-30
Substance CELECOXIB
Active strength 200 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-397-01 celecoxib 100 in 1 BOTTLE CAPSULE 100 15 68180-397-02 celecoxib 500 in 1 BOTTLE CAPSULE 500 15 68180-397-03 celecoxib 1000 in 1 BOTTLE CAPSULE 1000 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 68180-397 CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] 15 Legacy NDC, 3 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 68180-397-01 68180039701 100 CAPSULE in 1 BOTTLE (68180-397-01) 100 capsule 2016-03-17 2021-08-31 No No Current 68180-397-02 68180039702 500 CAPSULE in 1 BOTTLE (68180-397-02) 500 capsule 2015-10-01 2021-09-30 No No Current 68180-397-03 68180039703 1000 in 1 BOTTLE Historical