Home NDC 70069-362 Sulfamethoxazole and Trimethoprim
Product NDC 70069-362
11-digit product format 700690362
Labeler code 70069
Product ID 70069-362_012dfac7-9b72-48a5-a364-e62bbe150cfe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Somerset Therapeutics, LLC
Application ANDA212231
Marketing category ANDA
Marketing start 2019-08-29
Substance SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength 80; 16 mg/mL; mg/mL
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 43 .
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 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212231-001 AP
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 · 43 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 2026-09-14 22:38:34 2026-08 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212231-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 2019-06-26 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFAMETHOXAZOLE 80 mg/mL TRIMETHOPRIM 16 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AN164J8Y0X Internal UNII lookup JE42381TNV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313137 Internal RxNorm lookup 1809083 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 70069-362-01 Sulfamethoxazole and Trimethoprim 10 mL in 1 VIAL INJECTION, SOLUTION, CONCENTRATE 10 10 70069-362-10 Sulfamethoxazole and Trimethoprim 10 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 10 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-362 SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [SOMERSET THERAPEUTICS, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20230809_ebb570bb-6e5e-489e-875c-9e7b3a6d716a.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70069-362-01 70069036201 10 mL in 1 VIAL 10 ml Historical 70069-362-10 70069036210 10 VIAL in 1 CARTON (70069-362-10) / 10 mL in 1 VIAL (70069-362-01) 10 vial 2019-08-29 0000-00-00 No No Current