FDA.reportPublic FDA data

Sulfamethoxazole and Trimethoprim

Product NDC
70954-258
11-digit product format
709540258
Labeler code
70954
Product ID
70954-258_3c60334c-7cf5-4946-9fcf-e01c1dcff9e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA214330
Marketing category
ANDA
Marketing start
2022-02-08
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
200; 40 mg/5mL; mg/5mL
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethoxazole and Trimethoprim
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE200 mg/5mL
TRIMETHOPRIM40 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJE42381TNV, AN164J8Y0X
Rxcui313134

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-258-10Sulfamethoxazole and Trimethoprim473 mL in 1 BOTTLESUSPENSION4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-258-10ML - Milliliter70954-258bdf14058-6b16-42fc-afb9-892fc2f3c71912022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-258SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ANI PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20250206_5ff03694-787a-409d-a95e-8422aa27499c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN5ff03694-787a-409d-a95e-8422aa27499c7
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD5ff03694-787a-409d-a95e-8422aa27499c7
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY5ff03694-787a-409d-a95e-8422aa27499c7
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY5ff03694-787a-409d-a95e-8422aa27499c7
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY5ff03694-787a-409d-a95e-8422aa27499c7
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY5ff03694-787a-409d-a95e-8422aa27499c7
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNc6171b62-835c-465e-905e-97f70438186e2
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSN0b25c067-6c47-211c-e063-6294a90a7ca02
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCD0b25c067-6c47-211c-e063-6294a90a7ca02
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDc6171b62-835c-465e-905e-97f70438186e2
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYc6171b62-835c-465e-905e-97f70438186e2
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSY0b25c067-6c47-211c-e063-6294a90a7ca02
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYc6171b62-835c-465e-905e-97f70438186e2
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSY0b25c067-6c47-211c-e063-6294a90a7ca02
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYc6171b62-835c-465e-905e-97f70438186e2
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSY0b25c067-6c47-211c-e063-6294a90a7ca02
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSY0b25c067-6c47-211c-e063-6294a90a7ca02
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYc6171b62-835c-465e-905e-97f70438186e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-258-1070954025810473 mL in 1 BOTTLE (70954-258-10) 473 ml2022-02-080000-00-00NoNoCurrent