FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
66267-196
11-digit product format
662670196
Labeler code
66267
Product ID
66267-196_1fa6a784-9fb2-c3fa-e063-6394a90add4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2010-02-16
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Listing expiration
2026-12-31

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
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66267-196-062024-08-14C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-102024-08-14C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-142024-08-14C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-202024-08-14C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-282024-08-14C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-302024-08-14C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-602024-08-14C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-902024-08-14C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-062023-01-30C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-102023-01-30C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-142023-01-30C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-202023-01-30C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-282023-01-30C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-302023-01-30C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-602023-01-30C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP
66267-196-902023-01-30C16284748780-1f386c64a-2212-0266-e053-dadaa90a7c1aSulfamethoxazole and Trimethoprim Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-196-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET63
66267-196-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET103
66267-196-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET143
66267-196-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET203
66267-196-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET283
66267-196-30Sulfamethoxazole and Trimethoprim30 in 1 BOTTLETABLET303
66267-196-60Sulfamethoxazole and Trimethoprim60 in 1 BOTTLETABLET603
66267-196-90Sulfamethoxazole and Trimethoprim90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-196-06EA - Each66267-1963eb793d7-fc6f-4734-b408-91aa33ee41ac12016-11-08
66267-196-10EA - Each66267-1960eb839ee-34b4-4026-a0d1-a1cdc15b091812016-11-08
66267-196-14EA - Each66267-196b318e86f-4d1c-4814-8818-ebd238fd797912016-11-08
66267-196-20EA - Each66267-1967c0991f0-2bae-4a48-b4f2-65fc99bf585712016-11-08
66267-196-28EA - Each66267-19645d8c2cf-69c3-401c-9011-7132cb88bccf12016-11-08
66267-196-30EA - Each66267-196e5daa367-ea21-484c-8e8b-1acf4dafeedc12016-11-08
66267-196-60EA - Each66267-1967a357b0c-15b8-4379-ba20-581de98b541b12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-196SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NUCARE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 8 package rows20240815_3ed6bf70-2841-04f8-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3ed6bf70-2841-04f8-e054-00144ff8d46c3
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3ed6bf70-2841-04f8-e054-00144ff8d46c3
198335SMX 800 MG / TMP 160 MG Oral TabletSY3ed6bf70-2841-04f8-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-196-06662670196066 TABLET in 1 BOTTLE (66267-196-06) 6 tablet2016-10-140000-00-00NoNoCurrent
66267-196-106626701961010 TABLET in 1 BOTTLE (66267-196-10) 10 tablet2016-10-140000-00-00NoNoCurrent
66267-196-146626701961414 TABLET in 1 BOTTLE (66267-196-14) 14 tablet2016-10-140000-00-00NoNoCurrent
66267-196-206626701962020 TABLET in 1 BOTTLE (66267-196-20) 20 tablet2016-10-140000-00-00NoNoCurrent
66267-196-286626701962828 TABLET in 1 BOTTLE (66267-196-28) 28 tablet2016-10-140000-00-00NoNoCurrent
66267-196-306626701963030 TABLET in 1 BOTTLE (66267-196-30) 30 tablet2016-10-140000-00-00NoNoCurrent
66267-196-606626701966060 TABLET in 1 BOTTLE (66267-196-60) 60 tablet2016-10-140000-00-00NoNoCurrent
66267-196-906626701969090 TABLET in 1 BOTTLE (66267-196-90) 90 tablet2016-10-140000-00-00NoNoCurrent