SULFATRIM

Product NDC
67296-1657
11-digit product format
672961657
Labeler code
67296
Product ID
67296-1657_1dfcbde9-641f-7454-e063-6394a90ad1e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA018615
Marketing category
NDA
Marketing start
1983-07-01
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
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1657IInactivated by FDA2026-08-17
excluded packagepackage67296-165767296-1657-1IInactivated by FDA2026-08-17
excluded packagepackage67296-165767296-1657-2IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1657-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1657-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1657-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1657-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1657-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1657-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1657-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1657-21332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N018615-001SULFATRIM PEDIATRICSULFAMETHOXAZOLE; TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07
N018615-002SULFATRIMSULFAMETHOXAZOLE; TRIMETHOPRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018615-001AB

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018615-001SULFATRIM PEDIATRIC200MG/5ML;40MG/5MLSUSPENSION / ORALAB1983-01-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018615-002SULFATRIM200MG/5ML;40MG/5MLSUSPENSION / ORAL1983-01-07bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018615-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018615-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018615-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018615-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018615-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018615-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018615-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018615-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018615-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018615-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018615-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018615-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018615-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018615-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018615-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018615-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018615-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018615-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018615-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018615-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018615-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018615-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018615-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018615-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018615-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018615-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018615-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018615-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018615-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018615-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018615-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018615-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018615-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018615-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018615-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018615-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018615-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018615-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018615-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018615-001AB1e64feba35796…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1657-1SULFATRIM100 mL in 1 BOTTLESUSPENSION1003
67296-1657-2SULFATRIM200 mL in 1 BOTTLESUSPENSION2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1657SULFATRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) SUSPENSION [REDPHARM DRUG, INC.]3Current NDC, Legacy NDC, 2 package rows20240725_b339af0b-4fa2-e8c3-e053-2995a90a6a34.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMA-S Medication Solutions80f7f00b-add4-4d6b-9e9c-bea29768c2392026-01-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 018615
application number: NDA018615
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMPAI Holdings, LLC dba PAI Pharmac62086ea-ba15-40f5-8431-4639c60c98252025-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 018615
application number: NDA018615
SULFATRIMSULFAMETHOXAZOLE AND TRIMETHOPRIMPreferred Pharmaceuticals, Inc.cd4932ce-0856-4e99-8baf-70afce1d7ffd2025-01-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 018615
application number: NDA018615
Sulfamethoxazole and TrimethoprimSULFAMETHOXAZOLE AND TRIMETHOPRIMPAI Holdings, LLC dba PAI Pharma777da85a-a776-4681-976d-326ec421cfc92024-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018615
application number: NDA018615

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313134sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral SuspensionPSNb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406SULFATRIM 200 MG / 40 MG in 5 mL Oral SuspensionPSNb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension [Sulfatrim]SBDb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral SuspensionSCDb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134SMX 40 MG/ML / TMP 8 MG/ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension [Sulfatrim]SYb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
313134sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343
208406Sulfatrim (sulfamethoxazole 200 MG / trimethoprim 40 MG) per 5 ML Oral SuspensionSYb339af0b-4fa2-e8c3-e053-2995a90a6a343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1657-167296165701100 mL in 1 BOTTLE (67296-1657-1) 100 ml1983-07-010000-00-00NoNoCurrent
67296-1657-267296165702200 mL in 1 BOTTLE (67296-1657-2) 200 ml1983-07-010000-00-00NoNoCurrent