Celecoxib

Product NDC: 59746-562
Requested package NDC: 59746-562-05
11-digit product format: 597460562
Labeler code: 59746
Product ID: 59746-562_c0ee4996-6a07-4e2e-aa45-54ebe2e5f5fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Jubilant Cadista Pharmaceuticals Inc.
Application: ANDA207061
Marketing category: ANDA
Marketing start: 2017-04-04
Marketing end: 0000-00-00
Substance: CELECOXIB
Active strength: 100 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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59746-562	59746-562-05	D	Discontinued by firm		2026-08-03

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A207061-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04
A207061-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04
A207061-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04
A207061-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A207061-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207061-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207061-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207061-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207061-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207061-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207061-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207061-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207061-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207061-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207061-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207061-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207061-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207061-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207061-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207061-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207061-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207061-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207061-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207061-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207061-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207061-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207061-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207061-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207061-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207061-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207061-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207061-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207061-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207061-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207061-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207061-004	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
59746-562-01	2026-01-05	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-05	2026-01-05	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-10	2026-01-05	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-30	2026-01-05	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-01	2023-01-30	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-05	2023-01-30	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-10	2023-01-30	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
59746-562-30	2023-01-30	These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59746-562	CELECOXIB (CELECOXIB) CAPSULE [JUBILANT CADISTA PHARMACEUTICALS INC.]	8	Legacy NDC	20210403_27d813ea-7798-09cb-734b-b970d7248f1f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JCX84Q7J1L	CELECOXIB	169590-42-5	CELECOXIB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59746-562-05	59746056205	500 CAPSULE in 1 BOTTLE (59746-562-05)	500 capsule	2017-04-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib	Jubilant Cadista Pharmaceuticals Inc. \| Jubilant Generics Limited \| Jubilant Generics Limited, Roorkee	2021-03-24	HUMAN PRESCRIPTION DRUG LABEL	8