Sulfamethoxazole and Trimethoprim

Product NDC
70954-258
Requested package NDC
70954-258-10
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214330-001AB

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
2026-09-14 22:38:342026-08A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-0884e616aacf4f…
2026-08-18 06:07:402026-07A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214330-001SULFAMETHOXAZOLE AND TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB2022-02-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214330-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A214330-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214330-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214330-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214330-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214330-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214330-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214330-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214330-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214330-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214330-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214330-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214330-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214330-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214330-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214330-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214330-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214330-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214330-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214330-001AB1bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214330-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214330-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214330-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214330-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214330-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214330-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214330-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A214330-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A214330-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214330-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214330-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214330-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214330-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214330-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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
313134Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ff03694-787a-409d-a95e-8422aa27499cAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPreferred Pharmaceuticals Inc.c6171b62-835c-465e-905e-97f70438186e2026-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214330
application number: ANDA214330
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMANI Pharmaceuticals, Inc.5ff03694-787a-409d-a95e-8422aa27499c2026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214330
application number: ANDA214330
ndc (package): 70954-258-10
ndc (product): 70954-258
ndc11 (package): 70954025810

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