Sulfamethoxazole and Trimethoprim

Product NDC: 60687-603
11-digit product format: 606870603
Labeler code: 60687
Product ID: 60687-603_ea798f52-951a-6540-e053-2a95a90a5dfc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA090624
Marketing category: ANDA
Marketing start: 2022-01-31
Marketing end: 0000-00-00
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 400 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
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

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
60687-603-11	Sulfamethoxazole and Trimethoprim	1 in 1 BLISTER PACK	TABLET	1		6
60687-603-65	Sulfamethoxazole and Trimethoprim	50 in 1 BOX, UNIT-DOSE	TABLET	50		6

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-603-11	EA - Each	60687-603	fe54245b-7d73-4ce4-a3da-451154cbbc44	1	2022-01-06
60687-603-65	EA - Each	60687-603	807e1465-db0d-4809-a7b6-35606348c9ab	1	2022-01-06

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-603	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]	5	Legacy NDC, 2 package rows	20241120_7f25bff3-0e86-4bec-b293-54b68347867f.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
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	PSN	7f25bff3-0e86-4bec-b293-54b68347867f	6
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	7f25bff3-0e86-4bec-b293-54b68347867f	6
198334	sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet	SCD	7f25bff3-0e86-4bec-b293-54b68347867f	6
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	7f25bff3-0e86-4bec-b293-54b68347867f	6
198334	SMX 400 MG / TMP 80 MG Oral Tablet	SY	7f25bff3-0e86-4bec-b293-54b68347867f	6
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	7f25bff3-0e86-4bec-b293-54b68347867f	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-603-11	60687060311	1 in 1 BLISTER PACK						Historical
60687-603-21	60687060321	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-21) > 1 TABLET in 1 BLISTER PACK (60687-603-11)	30 blister pack	2021-06-01	0000-00-00	No	No	Current
60687-603-65	60687060365	50 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-603-65) > 1 TABLET in 1 BLISTER PACK (60687-603-11)	50 blister pack	2021-07-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim Tablets, USP 8460321/0325	American Health Packaging	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	6