FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
60687-614
11-digit product format
606870614
Labeler code
60687
Product ID
60687-614_3a9d0d40-7169-877e-e063-6294a90a82f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090624
Marketing category
ANDA
Marketing start
2022-01-03
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
Rxcui198334, 198335

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
60687-614-01Sulfamethoxazole and Trimethoprim100 in 1 BOX, UNIT-DOSETABLET1006
60687-614-11Sulfamethoxazole and Trimethoprim1 in 1 BLISTER PACKTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-614-01EA - Each60687-614a9f9532c-e808-4dca-81b3-3941120f554c12022-01-06
60687-614-11EA - Each60687-614774935c8-17a6-458e-a100-b61a141be59c12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-614SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20241120_7f25bff3-0e86-4bec-b293-54b68347867f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSN7f25bff3-0e86-4bec-b293-54b68347867f6
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN7f25bff3-0e86-4bec-b293-54b68347867f6
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCD7f25bff3-0e86-4bec-b293-54b68347867f6
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD7f25bff3-0e86-4bec-b293-54b68347867f6
198334SMX 400 MG / TMP 80 MG Oral TabletSY7f25bff3-0e86-4bec-b293-54b68347867f6
198335SMX 800 MG / TMP 160 MG Oral TabletSY7f25bff3-0e86-4bec-b293-54b68347867f6
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN08500fcb-dbec-4ac2-91c3-189d27907ec01
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD08500fcb-dbec-4ac2-91c3-189d27907ec01
198335SMX 800 MG / TMP 160 MG Oral TabletSY08500fcb-dbec-4ac2-91c3-189d27907ec01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-614-0160687061401100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-614-01) / 1 TABLET in 1 BLISTER PACK (60687-614-11) 100 blister pack2022-01-030000-00-00NoNoCurrent
60687-614-11606870614111 in 1 BLISTER PACKHistorical