FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
55700-611
11-digit product format
557000611
Labeler code
55700
Product ID
55700-611_b44a332e-98a1-4f1b-b06b-3a9b044cb926
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA090624
Marketing category
ANDA
Marketing start
2018-05-04
Marketing end
2028-11-30
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#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE800 mg/1
TRIMETHOPRIM160 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui198335

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-611-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET612
55700-611-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET1012
55700-611-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET1412
55700-611-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET2012
55700-611-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET2812
55700-611-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-611-06EA - Each55700-611966445f2-28b0-4c4f-ad3a-4f6308ab54c512019-02-13
55700-611-10EA - Each55700-6112d61ab8e-7be8-40ee-9009-4a3e7659e39f12018-06-11
55700-611-14EA - Each55700-611525aaaa8-948e-4c03-bcdf-2825896500a812018-06-11
55700-611-20EA - Each55700-611840735f2-d4a9-4a27-9445-c212e84b5eae12018-06-11
55700-611-28EA - Each55700-611909eaf73-9a26-402a-8e16-ef5e39bcfdc812018-06-11
55700-611-30EA - Each55700-611e8b39231-f46a-41fe-9cdc-bf57f0c2ff9b12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-611SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [QUALITY CARE PRODUCTS LLC]12Current NDC, Legacy NDC, 6 package rows20241219_079c828c-148f-45b9-966e-d8906043b2a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN079c828c-148f-45b9-966e-d8906043b2a212
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD079c828c-148f-45b9-966e-d8906043b2a212
198335SMX 800 MG / TMP 160 MG Oral TabletSY079c828c-148f-45b9-966e-d8906043b2a212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-611-06557000611066 TABLET in 1 BOTTLE (55700-611-06) 6 tablet2019-01-110000-00-00NoNoCurrent
55700-611-105570006111010 TABLET in 1 BOTTLE (55700-611-10) 10 tablet2018-05-040000-00-00NoNoCurrent
55700-611-145570006111414 TABLET in 1 BOTTLE (55700-611-14) 14 tablet2018-05-040000-00-00NoNoCurrent
55700-611-205570006112020 TABLET in 1 BOTTLE (55700-611-20) 20 tablet2018-05-042028-11-30NoNoCurrent
55700-611-285570006112828 TABLET in 1 BOTTLE (55700-611-28) 28 tablet2018-05-040000-00-00NoNoCurrent
55700-611-305570006113030 TABLET in 1 BOTTLE (55700-611-30) 30 tablet2018-11-020000-00-00NoNoCurrent