FDA.reportPublic FDA data

Trimethoprim

Product NDC
40032-330
11-digit product format
400320330
Labeler code
40032
Product ID
40032-330_63ba2637-37db-4f1e-b488-6e53466a5028
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA091437
Marketing category
ANDA
Marketing start
2014-03-04
Substance
TRIMETHOPRIM
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIMETHOPRIM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAN164J8Y0X
Rxcui198332

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-330-24Trimethoprim100 in 1 BOTTLETABLET1003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XTRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.]2
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XTRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RTRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-330TRIMETHOPRIM TABLET [NOVEL LABORATORIES, INC.]3Current NDC, Legacy NDC, 1 package rows20171130_b27e43b5-670b-43f6-b28b-413e54f914da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198332trimethoprim 100 MG Oral TabletPSNb27e43b5-670b-43f6-b28b-413e54f914da3
198332trimethoprim 100 MG Oral TabletSCDb27e43b5-670b-43f6-b28b-413e54f914da3
198332TMP 100 MG Oral TabletSYb27e43b5-670b-43f6-b28b-413e54f914da3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-330-2440032033024100 TABLET in 1 BOTTLE (40032-330-24) 100 tablet2014-03-040000-00-00NoNoCurrent