Sulindac

Product NDC: 0591-5660
11-digit product format: 005915660
Labeler code: 0591
Product ID: 0591-5660_988f11c7-805d-4926-84b3-4c9c0cb0038d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulindac
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA071795
Marketing category: ANDA
Marketing start: 1990-04-03
Substance: SULINDAC
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
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Sulindac
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULINDAC	200 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	184SNS8VUH
Rxcui	198238, 198239

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c7c8244c-3606-b814-8453-06ab13fc5907	Product name	2	20201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-5660-01	Sulindac	100 in 1 BOTTLE, PLASTIC	TABLET	100		13
0591-5660-05	Sulindac	500 in 1 BOTTLE, PLASTIC	TABLET	500		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-5660-01	EA - Each	0591-5660	98f8fecf-671b-4aa6-8fe0-1cc7acf2a3a7	1	2012-07-24
0591-5660-05	EA - Each	0591-5660	cda187ef-9dea-47a2-9bcf-c2bfd298b1bc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULINDAC	ACTIVE INGREDIENT	184SNS8VUH	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
SULINDAC	ACTIVE INGREDIENT	184SNS8VUH	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
SULINDAC	ACTIVE INGREDIENT	184SNS8VUH	SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SULINDAC	ACTIVE MOIETY	184SNS8VUH	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
SULINDAC	ACTIVE MOIETY	184SNS8VUH	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
SULINDAC	ACTIVE MOIETY	184SNS8VUH	SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SULINDAC TABLET [CARILION MATERIALS MANAGEMENT]	2
SULINDAC	ACTIVE INGREDIENT	184SNS8VUH	SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]	1
SULINDAC	ACTIVE INGREDIENT	184SNS8VUH	SULINDAC TABLET [WATSON LABORATORIES, INC.]	1
SULINDAC	ACTIVE INGREDIENT	184SNS8VUH	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1
SULINDAC	ACTIVE MOIETY	184SNS8VUH	SULINDAC TABLET [WATSON LABORATORIES, INC.]	1
SULINDAC	ACTIVE MOIETY	184SNS8VUH	SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]	1
SULINDAC	ACTIVE MOIETY	184SNS8VUH	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SULINDAC TABLET [WATSON LABORATORIES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULINDAC TABLET [WATSON LABORATORIES, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULINDAC TABLET [WATSON LABORATORIES, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SULINDAC TABLET [WATSON LABORATORIES, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SULINDAC TABLET [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-5660	SULINDAC TABLET [ACTAVIS PHARMA, INC.]	13	Current NDC, Legacy NDC, 2 package rows	20241210_d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
184SNS8VUH	SULINDAC	38194-50-2	SULINDAC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198239	sulindac 200 MG Oral Tablet	PSN	68d4eeed-2501-494b-b979-502720de86c0	14
198239	sulindac 200 MG Oral Tablet	SCD	68d4eeed-2501-494b-b979-502720de86c0	14
198238	sulindac 150 MG Oral Tablet	PSN	d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4	13
198239	sulindac 200 MG Oral Tablet	PSN	d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4	13
198238	sulindac 150 MG Oral Tablet	SCD	d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4	13
198239	sulindac 200 MG Oral Tablet	SCD	d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4	13
198238	sulindac 150 MG Oral Tablet	PSN	b906d325-27f1-4fb4-86ab-a2c896470e1e	2
198239	sulindac 200 MG Oral Tablet	PSN	a399a9e2-5413-434c-ae1a-26ac7b796082	2
198239	sulindac 200 MG Oral Tablet	PSN	b8b549e9-53ec-407a-a505-b652faf8f3b6	2
198239	sulindac 200 MG Oral Tablet	PSN	b906d325-27f1-4fb4-86ab-a2c896470e1e	2
198238	sulindac 150 MG Oral Tablet	SCD	b906d325-27f1-4fb4-86ab-a2c896470e1e	2
198239	sulindac 200 MG Oral Tablet	SCD	a399a9e2-5413-434c-ae1a-26ac7b796082	2
198239	sulindac 200 MG Oral Tablet	SCD	b8b549e9-53ec-407a-a505-b652faf8f3b6	2
198239	sulindac 200 MG Oral Tablet	SCD	b906d325-27f1-4fb4-86ab-a2c896470e1e	2
198239	sulindac 200 MG Oral Tablet	PSN	145a1b4a-16ef-4f29-b47e-f52c47514c9a	1
198239	sulindac 200 MG Oral Tablet	SCD	145a1b4a-16ef-4f29-b47e-f52c47514c9a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-5660-01	00591566001	100 TABLET in 1 BOTTLE, PLASTIC (0591-5660-01)	100 tablet	1990-04-03	0000-00-00	No	No	Current
0591-5660-05	00591566005	500 TABLET in 1 BOTTLE, PLASTIC (0591-5660-05)	500 tablet	1990-04-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulindac Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-03-20	HUMAN PRESCRIPTION DRUG LABEL	14
Sulindac Tablets, USP Rx only	Actavis Pharma, Inc.	2024-10-22	HUMAN PRESCRIPTION DRUG LABEL	13
Sulindac Tablets USP Revised: June 2009 Rx only 190770	H.J. Harkins Company, Inc. \| Watson Laboratories, Inc. \| Watson Laboratories, Inc. - Florida \| Watson Pharma Private Limited	2011-10-28	HUMAN PRESCRIPTION DRUG LABEL	1
Sulindac Tablets USP Revised: June 2009 Rx only 190770	Carilion Materials Management	2010-07-12	HUMAN PRESCRIPTION DRUG LABEL	2
Sulindac Tablets USP Revised: June 2009 Rx only 190770	Carilion Materials Management	2010-07-12	HUMAN PRESCRIPTION DRUG LABEL	2
Sulindac Tablets USP Revised: June 2009 Rx only 190770	Physicians Total Care, Inc.	2010-07-12	HUMAN PRESCRIPTION DRUG LABEL	2

Sulindac

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#