FDA.reportPublic FDA data

Bactrim DS

Product NDC
49708-146
11-digit product format
497080146
Labeler code
49708
Product ID
49708-146_2a76a544-1f84-4b42-e063-6394a90a08d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc
Application
NDA017377
Marketing category
NDA
Marketing start
2004-11-01
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
Bactrim DS
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAN164J8Y0X, JE42381TNV
Rxcui198334, 198335, 208416, 849580

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
49708-146-01Bactrim DS100 in 1 BOTTLE, PLASTICTABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49708-146-01EA - Each49708-14645c6c14e-c84d-4d01-ba83-72448cbc2cd012014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sulfamethoxazoleACTIVE INGREDIENTJE42381TNVBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
TrimethoprimACTIVE INGREDIENTAN164J8Y0XBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
sulfamethoxazoleACTIVE MOIETYJE42381TNVBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
TrimethoprimACTIVE MOIETYAN164J8Y0XBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
Docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0BACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30BACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
Sodium benzoateINACTIVE INGREDIENTOJ245FE5EUBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2BACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49708-146BACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC]18Current NDC, Legacy NDC, 1 package rows20250101_f59d0c04-9c66-4d53-a0e1-cb55570deb62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208416Bactrim 400 MG /80 MG Oral TabletPSNf59d0c04-9c66-4d53-a0e1-cb55570deb6218
849580Bactrim DS 800 MG/ 160 MG Oral TabletPSNf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSNf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNf59d0c04-9c66-4d53-a0e1-cb55570deb6218
208416sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet [Bactrim]SBDf59d0c04-9c66-4d53-a0e1-cb55570deb6218
849580sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet [Bactrim]SBDf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCDf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDf59d0c04-9c66-4d53-a0e1-cb55570deb6218
208416Bactrim 400 MG / 80 MG Oral TabletSYf59d0c04-9c66-4d53-a0e1-cb55570deb6218
849580Bactrim DS 800 MG / 160 MG Oral TabletSYf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198334SMX 400 MG / TMP 80 MG Oral TabletSYf59d0c04-9c66-4d53-a0e1-cb55570deb6218
208416SMX 400 MG / TMP 80 MG Oral Tablet [Bactrim]SYf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198335SMX 800 MG / TMP 160 MG Oral TabletSYf59d0c04-9c66-4d53-a0e1-cb55570deb6218
849580SMX 800 MG / TMP 160 MG Oral Tablet [Bactrim]SYf59d0c04-9c66-4d53-a0e1-cb55570deb6218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49708-146-0149708014601100 TABLET in 1 BOTTLE, PLASTIC (49708-146-01) 100 tablet2004-11-010000-00-00NoNoCurrent