Sulfamethoxazole and Trimethoprim

Product NDC
21695-125
11-digit product format
216950125
Labeler code
21695
Product ID
21695-125_78b559bd-44e8-45d2-96dc-5827b5f2caec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA076899
Marketing category
ANDA
Marketing start
2010-02-25
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-125-05Sulfamethoxazole and Trimethoprim05 in 1 BOTTLETABLET052
21695-125-06Sulfamethoxazole and Trimethoprim06 in 1 BOTTLETABLET062
21695-125-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET102
21695-125-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET142
21695-125-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET202
21695-125-21Sulfamethoxazole and Trimethoprim21 in 1 BOTTLETABLET212
21695-125-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET282
21695-125-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET302
21695-125-40Sulfamethoxazole and Trimethoprim40 in 1 BOTTLETABLET402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-125-05EA - Each21695-125b1503b50-9cdc-4607-a4fb-23c328c9930c12012-07-24
21695-125-06EA - Each21695-12530ed140d-8b52-4ebe-b8c3-d12b685a255512012-07-24
21695-125-10EA - Each21695-125705dd324-8c1a-419d-a70c-1a0d4f19877612012-07-24
21695-125-14EA - Each21695-125ce741d5a-3492-4c9f-9dbc-5446d1a2c43c12012-07-24
21695-125-20EA - Each21695-125e941b570-51a0-4751-bcf6-4aa2c8af94ae12012-07-24
21695-125-21EA - Each21695-1258af7b757-ff19-41c2-a9e9-83ab3d76ddb612012-07-24
21695-125-28EA - Each21695-125ac0cf69a-34c6-44ef-92d7-8170471442c612012-07-24
21695-125-30EA - Each21695-1253d3835b2-307c-4c85-b511-db64bfaa4c4712012-07-24
21695-125-40EA - Each21695-12553e17df3-3c30-46e3-b009-9117c8fbb81012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-125SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REBEL DISTRIBUTORS CORP.]2Legacy NDC, 9 package rows20110620_2bc4adb5-cac5-4b8b-bc92-35bcc0321e82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN2bc4adb5-cac5-4b8b-bc92-35bcc0321e822
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD2bc4adb5-cac5-4b8b-bc92-35bcc0321e822
198335SMX 800 MG / TMP 160 MG Oral TabletSY2bc4adb5-cac5-4b8b-bc92-35bcc0321e822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-125-052169501250505 in 1 BOTTLEHistorical
21695-125-062169501250606 in 1 BOTTLEHistorical
21695-125-102169501251010 in 1 BOTTLEHistorical
21695-125-142169501251414 in 1 BOTTLEHistorical
21695-125-202169501252020 in 1 BOTTLEHistorical
21695-125-212169501252121 in 1 BOTTLEHistorical
21695-125-282169501252828 in 1 BOTTLEHistorical
21695-125-302169501253030 in 1 BOTTLEHistorical
21695-125-402169501254040 in 1 BOTTLEHistorical