Sulfamethoxazole and Trimethoprim

Product NDC: 63629-6799
11-digit product format: 636296799
Labeler code: 63629
Product ID: 63629-6799_63ece2e2-ceb2-49d0-b1de-2da699fe8220
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA071017
Marketing category: ANDA
Marketing start: 1986-08-25
Marketing end: 0000-00-00
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 400 mg/1; mg/1
Pharmacologic classes: Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-6799-1	2020-10-16	C162847	48780-1	9d75b9cf-ff0e-f424-e053-dadaa90a57ce	bc1a57ce-3890-4dc0-924f-4b68a5399cef
63629-6799-1	2020-01-31	C162847	48780-1	9d75b9cf-ff0e-f424-e053-dadaa90a57ce	bc1a57ce-3890-4dc0-924f-4b68a5399cef

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
63629-6799-1	63629679901	14 TABLET in 1 BOTTLE (63629-6799-1)	14 tablet	2015-09-28	0000-00-00	No	No	Current