Celecoxib

Product NDC: 60505-3849
11-digit product format: 605053849
Labeler code: 60505
Product ID: 60505-3849_3f02b96b-79f0-71a0-fd31-ab495401b187
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Celecoxib
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA204197
Marketing category: ANDA
Marketing start: 2015-06-03
Marketing end: 2027-05-31
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
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Celecoxib

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CELECOXIB	200 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	JCX84Q7J1L
Rxcui	205322, 205323, 686379

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9a	Product name	1	20200925
827beb42-45f2-95b8-6aa3-f35174375422	Product name	9	20160429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-3849-1	Celecoxib	100 in 1 BOTTLE	CAPSULE	100	25
60505-3849-3	Celecoxib	30 in 1 BOTTLE	CAPSULE	30	25
60505-3849-5	Celecoxib	500 in 1 BOTTLE	CAPSULE	500	25
60505-3849-8	Celecoxib	1000 in 1 BOTTLE	CAPSULE	1000	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-3849-1	EA - Each	60505-3849	d5605868-1f41-4ca1-a737-f4f1292898a5	1	2015-07-20
60505-3849-5	EA - Each	60505-3849	7389baf4-e339-4f25-8df0-8958d352565d	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Celecoxib	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [APOTEX CORP.]	11
Celecoxib	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [APOTEX CORP.]	11
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CELECOXIB CAPSULE [APOTEX CORP.]	11
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CELECOXIB CAPSULE [APOTEX CORP.]	11
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	CELECOXIB CAPSULE [APOTEX CORP.]	11
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CELECOXIB CAPSULE [APOTEX CORP.]	11
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CELECOXIB CAPSULE [APOTEX CORP.]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CELECOXIB CAPSULE [APOTEX CORP.]	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CELECOXIB CAPSULE [APOTEX CORP.]	11
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CELECOXIB CAPSULE [APOTEX CORP.]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [APOTEX CORP.]	11
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CELECOXIB CAPSULE [APOTEX CORP.]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [APOTEX CORP.]	11
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [APOTEX CORP.]	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [APOTEX CORP.]	11
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [APOTEX CORP.]	11
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CELECOXIB CAPSULE [APOTEX CORP.]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [APOTEX CORP.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [APOTEX CORP.]	11
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Celecoxib	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
CELECOXIB	ACTIVE INGREDIENT	JCX84Q7J1L	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
Celecoxib	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
CELECOXIB	ACTIVE MOIETY	JCX84Q7J1L	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
POVIDONE K12	INACTIVE INGREDIENT	333AG72FWJ	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CELECOXIB CAPSULE [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3849	CELECOXIB CAPSULE [APOTEX CORP.]	24	Current NDC, Legacy NDC, 4 package rows	20250302_a62612b3-9564-2b34-be59-6aa5ac53679c.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205323	celecoxib 200 MG Oral Capsule	PSN	52572bfb-43f0-4b55-b1fd-231a05c8b83e	32
205323	celecoxib 200 MG Oral Capsule	SCD	52572bfb-43f0-4b55-b1fd-231a05c8b83e	32
205322	celecoxib 100 MG Oral Capsule	PSN	a62612b3-9564-2b34-be59-6aa5ac53679c	25
205323	celecoxib 200 MG Oral Capsule	PSN	a62612b3-9564-2b34-be59-6aa5ac53679c	25
686379	celecoxib 50 MG Oral Capsule	PSN	a62612b3-9564-2b34-be59-6aa5ac53679c	25
205322	celecoxib 100 MG Oral Capsule	SCD	a62612b3-9564-2b34-be59-6aa5ac53679c	25
205323	celecoxib 200 MG Oral Capsule	SCD	a62612b3-9564-2b34-be59-6aa5ac53679c	25
686379	celecoxib 50 MG Oral Capsule	SCD	a62612b3-9564-2b34-be59-6aa5ac53679c	25
205322	celecoxib 100 MG Oral Capsule	PSN	2e1b6011-d3c7-63a0-e054-00144ff88e88	9
205322	celecoxib 100 MG Oral Capsule	PSN	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205323	celecoxib 200 MG Oral Capsule	PSN	2e1b6011-d3c7-63a0-e054-00144ff88e88	9
205323	celecoxib 200 MG Oral Capsule	PSN	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205322	celecoxib 100 MG Oral Capsule	SCD	2e1b6011-d3c7-63a0-e054-00144ff88e88	9
205322	celecoxib 100 MG Oral Capsule	SCD	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205323	celecoxib 200 MG Oral Capsule	SCD	370b2bb0-8fb7-4e42-8ec4-e14bae2c4a46	9
205323	celecoxib 200 MG Oral Capsule	SCD	2e1b6011-d3c7-63a0-e054-00144ff88e88	9
205323	celecoxib 200 MG Oral Capsule	PSN	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	7
205323	celecoxib 200 MG Oral Capsule	SCD	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	7
205323	celecoxib 200 MG Oral Capsule	PSN	6c56cfd5-f5e2-cbdd-e053-2991aa0a2e1a	4
205323	celecoxib 200 MG Oral Capsule	SCD	6c56cfd5-f5e2-cbdd-e053-2991aa0a2e1a	4
205323	celecoxib 200 MG Oral Capsule	PSN	6dd743d3-4821-4919-90eb-6d306ca7999f	3
205323	celecoxib 200 MG Oral Capsule	SCD	6dd743d3-4821-4919-90eb-6d306ca7999f	3
205323	celecoxib 200 MG Oral Capsule	PSN	a76b143e-70c7-41da-b40b-adee661f0a60	2
205323	celecoxib 200 MG Oral Capsule	PSN	23e5c271-3d06-5a63-e054-00144ff8d46c	2
205323	celecoxib 200 MG Oral Capsule	SCD	a76b143e-70c7-41da-b40b-adee661f0a60	2
205323	celecoxib 200 MG Oral Capsule	SCD	23e5c271-3d06-5a63-e054-00144ff8d46c	2
205323	celecoxib 200 MG Oral Capsule	PSN	8e859901-e41c-420b-e053-2995a90ae09a	1
205323	celecoxib 200 MG Oral Capsule	PSN	56d1e6f1-7b59-3d73-e054-00144ff8d46c	1
205323	celecoxib 200 MG Oral Capsule	SCD	8e859901-e41c-420b-e053-2995a90ae09a	1
205323	celecoxib 200 MG Oral Capsule	SCD	56d1e6f1-7b59-3d73-e054-00144ff8d46c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-3849-1	60505384901	100 CAPSULE in 1 BOTTLE (60505-3849-1)	100 capsule	2015-06-03	2027-05-31	No	No	Current
60505-3849-3	60505384903	30 CAPSULE in 1 BOTTLE (60505-3849-3)	30 capsule	2015-06-03	0000-00-00	No	No	Current
60505-3849-5	60505384905	500 CAPSULE in 1 BOTTLE (60505-3849-5)	500 capsule	2015-06-03	2027-03-31	No	No	Current
60505-3849-8	60505384908	1000 CAPSULE in 1 BOTTLE (60505-3849-8)	1000 capsule	2015-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celecoxib	PD-Rx Pharmaceuticals, Inc.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	32
Celecoxib	Apotex Corp. \| Apotex Inc.	2026-04-17	HUMAN PRESCRIPTION DRUG LABEL	25
Celecoxib	Major Pharmaceuticals	2025-03-11	HUMAN PRESCRIPTION DRUG LABEL	9
Celecoxib	A-S Medication Solutions	2024-09-18	HUMAN PRESCRIPTION DRUG LABEL	7
CELECOXIB	Direct_Rx	2023-04-18	HUMAN PRESCRIPTION DRUG LABEL	9
celecoxib 200	RedPharm Drug, Inc.	2022-01-21	HUMAN PRESCRIPTION DRUG LABEL	4
Celecoxib	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
CELECOXIB 200mg	Direct_Rx	2019-07-25	HUMAN PRESCRIPTION DRUG LABEL	1
Celecoxib	Unit Dose Services	2017-08-16	HUMAN PRESCRIPTION DRUG LABEL	2
Celecoxib	Mas Management Group, Inc.	2017-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
Celecoxib	Blenheim Pharmacal, Inc.	2016-04-21	HUMAN PRESCRIPTION DRUG LABEL	2

Celecoxib

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#