Sulfamethoxazole and Trimethoprim

Product NDC: 0904-2725
11-digit product format: 009042725
Labeler code: 0904
Product ID: 0904-2725_9a4352b9-fe91-4c7b-b066-533be5c840f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA076899
Marketing category: ANDA
Marketing start: 2010-09-13
Marketing end: 2027-03-31
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 800; 160 mg/1; mg/1
Pharmacologic classes: Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]
NDC exclude flag: No
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
SULFAMETHOXAZOLE	800 mg/1
TRIMETHOPRIM	160 mg/1

Field, Values table
Field	Values
Unii	JE42381TNV, AN164J8Y0X
Rxcui	198335

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ce811b5-329e-27f8-b5ff-66d52b435c00	Product name	3	20240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27	Product name	3	20221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fad	Product name	3	20190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-2725-61	Sulfamethoxazole and Trimethoprim	100 in 1 CARTON	TABLET	100		18
0904-2725-61	Sulfamethoxazole and Trimethoprim	1 in 1 BLISTER PACK	TABLET	1		18

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-2725-40	EA - Each	0904-2725	309a6f5a-7a9f-4466-8d83-24e7b1633a3d	1	2012-07-24
0904-2725-60	EA - Each	0904-2725	84e4f990-5cb8-4b71-9954-cdbff531d2a1	1	2012-07-24
0904-2725-61	EA - Each	0904-2725	a7eef1e1-21bf-43ef-9826-eaedbcd63c25	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SULFAMETHOXAZOLE	ACTIVE INGREDIENT	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]	8
TRIMETHOPRIM	ACTIVE INGREDIENT	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]	8
SULFAMETHOXAZOLE	ACTIVE MOIETY	JE42381TNV	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]	8
TRIMETHOPRIM	ACTIVE MOIETY	AN164J8Y0X	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]	8
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]	8

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-2725	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS]	16	Current NDC, Legacy NDC, 2 package rows	20250214_abe0d2d5-4879-4b4e-9b57-47ea83a17ba0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JE42381TNV	SULFAMETHOXAZOLE	723-46-6	SULFAMETHOXAZOLE
AN164J8Y0X	TRIMETHOPRIM	738-70-5	TRIMETHOPRIM

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	abe0d2d5-4879-4b4e-9b57-47ea83a17ba0	18
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	abe0d2d5-4879-4b4e-9b57-47ea83a17ba0	18
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	abe0d2d5-4879-4b4e-9b57-47ea83a17ba0	18
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	5dc03027-cdaf-461f-87fd-630d382fc723	8
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	5dc03027-cdaf-461f-87fd-630d382fc723	8
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	5dc03027-cdaf-461f-87fd-630d382fc723	8

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-2725-61	00904272561	100 BLISTER PACK in 1 CARTON (0904-2725-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2010-09-13	2027-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim Tablets, USP (800 mg/160 mg (double strength) and 400 mg/80 mg) Rx only	Cardinal Health 107, LLC	2025-11-21	HUMAN PRESCRIPTION DRUG LABEL	8
Sulfamethoxazole and Trimethoprim Tablets, USP (800 mg/160 mg (double strength) and 400 mg/80 mg) Rx only	Major Pharmaceuticals	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL	18