Sulfamethoxazole and Trimethoprim

Product NDC: 63629-7671
11-digit product format: 636297671
Labeler code: 63629
Product ID: 63629-7671_c0e9a5a5-ec33-44bf-ba69-8b64f625d015
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076899
Marketing category: ANDA
Marketing start: 2010-09-13
Marketing end: 0000-00-00
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 800 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-7671-1	2020-10-16	C162847	48780-1	9d75b9d0-0bb9-f424-e053-dadaa90a57ce	c086a32b-fc0d-4e39-8952-3557533bdbcb
63629-7671-1	2020-01-31	C162847	48780-1	9d75b9d0-0bb9-f424-e053-dadaa90a57ce	c086a32b-fc0d-4e39-8952-3557533bdbcb

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

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7671-1	63629767101	20 TABLET in 1 BOTTLE (63629-7671-1)	20 tablet	2010-09-13	0000-00-00	No	No	Current