FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
10544-525
11-digit product format
105440525
Labeler code
10544
Product ID
10544-525_18932962-88a2-63d3-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA076899
Marketing category
ANDA
Marketing start
2009-12-16
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-525-062020-01-31C16284748780-19d75b9d0-f760-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
10544-525-102020-01-31C16284748780-19d75b9d0-f760-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
10544-525-122020-01-31C16284748780-19d75b9d0-f760-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
10544-525-142020-01-31C16284748780-19d75b9d0-f760-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
10544-525-202020-01-31C16284748780-19d75b9d0-f760-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets
10544-525-282020-01-31C16284748780-19d75b9d0-f760-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-525-06Sulfamethoxazole and Trimethoprim6 in 1 BOTTLETABLET63
10544-525-10Sulfamethoxazole and Trimethoprim10 in 1 BOTTLETABLET103
10544-525-12Sulfamethoxazole and Trimethoprim12 in 1 BOTTLETABLET123
10544-525-14Sulfamethoxazole and Trimethoprim14 in 1 BOTTLETABLET143
10544-525-20Sulfamethoxazole and Trimethoprim20 in 1 BOTTLETABLET203
10544-525-28Sulfamethoxazole and Trimethoprim28 in 1 BOTTLETABLET283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-525-06EA - Each10544-525bc1d5304-a1d8-4825-9edb-b78a00a2c8fc12015-02-02
10544-525-10EA - Each10544-52572c0db5c-0611-45cf-ad66-08629e75d42e12015-02-02
10544-525-14EA - Each10544-5255981e5c1-0dcf-45ce-ad5a-ede1b8f0e25712015-02-02
10544-525-20EA - Each10544-5254199b54d-d16b-40c4-b870-dad4e321790f12015-02-02
10544-525-28EA - Each10544-5256d4c767b-a31d-4388-a67c-6dcf265a90bb12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFAMETHOXAZOLEACTIVE INGREDIENTJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]3
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]3
SULFAMETHOXAZOLEACTIVE MOIETYJE42381TNVSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]3
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ESULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-525SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.]3Legacy NDC, 6 package rows20150615_050b2f4e-d653-46ef-8235-4361598888c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN050b2f4e-d653-46ef-8235-4361598888c43
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD050b2f4e-d653-46ef-8235-4361598888c43
198335SMX 800 MG / TMP 160 MG Oral TabletSY050b2f4e-d653-46ef-8235-4361598888c43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-525-06105440525066 in 1 BOTTLEHistorical
10544-525-101054405251010 in 1 BOTTLEHistorical
10544-525-121054405251212 in 1 BOTTLEHistorical
10544-525-141054405251414 in 1 BOTTLEHistorical
10544-525-201054405252020 in 1 BOTTLEHistorical
10544-525-281054405252828 in 1 BOTTLEHistorical