FDA.reportPublic FDA data

Sulfamethox-TMP DS

Product NDC
54348-625
Requested package NDC
54348-625-20
11-digit product format
543480625
Labeler code
54348
Product ID
54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFAMETHOXAZOLE, TRIMETHOPRIM
Dosage form
TABLET
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA076899
Marketing category
ANDA
Marketing start
2019-07-11
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27
A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076899-001AB
A076899-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076899-001SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2005-01-27a50c72e98297…
2026-08-01 22:54:322026-06A076899-002SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2005-01-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076899-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A076899-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmneal Pharmaceuticals LLCf0e73842-6002-43c2-97fc-0cadc1bf63462026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAvKARE9f130443-c8e7-9122-8f27-f72f07f3f29e2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMNorthwind Health Company, LLCf2b8e9d9-1274-22ca-e053-2a95a90a6f1a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMCardinal Health 107, LLC5dc03027-cdaf-461f-87fd-630d382fc7232025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMMajor Pharmaceuticalsabe0d2d5-4879-4b4e-9b57-47ea83a17ba02025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d2025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMAmneal Pharmaceuticals of New York LLC3233c54d-484d-4550-b172-db8af47d1b7f2025-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and Trimethoprim DSSULFAMETHOXAZOLE AND TRIMETHOPRIMAdvanced Rx Pharmacy of Tennessee, LLCb001e648-2710-3ada-e053-2995a90a52f12024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMBryant Ranch Prepacka174991a-53e7-c791-3cee-b706a48e0ec52024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsf39a4c93-0a0e-4801-aecc-c55a2fa5e68b2024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsffc5d594-429c-4303-b3b6-f5a83e915b552024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions07a49665-fe2a-4a92-a57e-49db224b012e2024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions8661e318-ddf3-4a60-8781-6fa42307c60a2024-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutionsb85a58a7-74d6-4629-8027-0cdcbb5c815a2023-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions07da67b1-b50c-4471-8cde-8a119eb8c9352023-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
Sulfamethox-TMP DSSULFAMETHOXAZOLE, TRIMETHOPRIMPharmPak, Inc.ede74118-32c5-4f52-9823-509538e674c82022-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899
ndc (package): 54348-625-20
ndc (product): 54348-625
ndc11 (package): 54348062520
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMProficient Rx LP0df74ba1-1aa6-467c-92e7-6b017c7c6bce2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076899
application number: ANDA076899

Additional Listing Data#

Finished product
Yes
Brand name base
Sulfamethox-TMP DS
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JE42381TNVInternal UNII lookup
AN164J8Y0XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198335Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ede74118-32c5-4f52-9823-509538e674c8Available on FDA.report

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
54348-625-06Sulfamethox-TMP DS1 in 1 BOXTABLET12
54348-625-06Sulfamethox-TMP DS6 in 1 BOTTLETABLET62
54348-625-10Sulfamethox-TMP DS10 in 1 BOTTLETABLET102
54348-625-10Sulfamethox-TMP DS1 in 1 BOXTABLET12
54348-625-14Sulfamethox-TMP DS14 in 1 BOTTLETABLET142
54348-625-14Sulfamethox-TMP DS1 in 1 BOXTABLET12
54348-625-20Sulfamethox-TMP DS1 in 1 BOXTABLET12
54348-625-20Sulfamethox-TMP DS20 in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-625SULFAMETHOX-TMP DS (SULFAMETHOXAZOLE, TRIMETHOPRIM) TABLET [PHARMPAK, INC.]2Current NDC, Legacy NDC, 8 package rows20221011_ede74118-32c5-4f52-9823-509538e674c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNede74118-32c5-4f52-9823-509538e674c82
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDede74118-32c5-4f52-9823-509538e674c82
198335SMX 800 MG / TMP 160 MG Oral TabletSYede74118-32c5-4f52-9823-509538e674c82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-625-20543480625201 BOTTLE in 1 BOX (54348-625-20) / 20 TABLET in 1 BOTTLE1 bottle2019-07-110000-00-00NoNoCurrent