Home NDC 60687-442 Sulfamethoxazole and Trimethoprim
Product NDC 60687-442
11-digit product format 606870442
Labeler code 60687
Product ID 60687-442_3546bee9-e4fa-333e-e063-6394a90a4200
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form SUSPENSION
Route ORAL
Labeler American Health Packaging
Application ANDA091348
Marketing category ANDA
Marketing start 2024-11-07
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091348-001 AB
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 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sulfamethoxazole and Trimethoprim
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFAMETHOXAZOLE 200 mg/5mL TRIMETHOPRIM 40 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JE42381TNV Internal UNII lookup AN164J8Y0X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313134 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60687-442-24 Sulfamethoxazole and Trimethoprim 20 mL in 1 CUP, UNIT-DOSE SUSPENSION 20 3 60687-442-53 Sulfamethoxazole and Trimethoprim 10 in 1 TRAY SUSPENSION 10 3 60687-442-75 Sulfamethoxazole and Trimethoprim 4 in 1 CASE SUSPENSION 4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-442 SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [AMERICAN HEALTH PACKAGING] 3 Current NDC, 3 package rows 20250521_f14b8d07-e73b-4ceb-bd6a-578c961b7c09.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60687-442-24 60687044224 20 mL in 1 CUP, UNIT-DOSE 20 ml Historical 60687-442-53 60687044253 10 in 1 TRAY Historical 60687-442-75 60687044275 4 TRAY in 1 CASE (60687-442-75) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-442-53) / 20 mL in 1 CUP, UNIT-DOSE (60687-442-24) 4 tray 2024-11-07 No No Current