Home NDC 0703-9503 Sulfamethoxazole and Trimethoprim
Product NDC 0703-9503
11-digit product format 007039503
Labeler code 0703
Product ID 0703-9503_75bddfb3-c199-47a4-b54a-a74cef7dec9a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA073303
Marketing category ANDA
Marketing start 1991-11-01
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 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073303-001 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 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION 1991-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION 1991-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION 1991-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP RS 1991-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073303-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 80MG/ML;16MG/ML INJECTABLE / INJECTION AP 1991-10-31 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 0703-9503-01 Sulfamethoxazole and Trimethoprim 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 5 18 0703-9503-03 Sulfamethoxazole and Trimethoprim 10 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 10 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFAMETHOXAZOLE ACTIVE INGREDIENT JE42381TNV SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 TRIMETHOPRIM ACTIVE INGREDIENT AN164J8Y0X SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 SULFAMETHOXAZOLE ACTIVE MOIETY JE42381TNV SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 TRIMETHOPRIM ACTIVE MOIETY AN164J8Y0X SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 ALCOHOL INACTIVE INGREDIENT 3K9958V90M SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 DIETHANOLAMINE INACTIVE INGREDIENT AZE05TDV2V SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9 WATER INACTIVE INGREDIENT 059QF0KO0R SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0703-9503 SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] 17 Current NDC, Legacy NDC, 2 package rows 20250510_b89b5502-ce87-45a6-a43c-9891da3cfca4.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 · 3 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 0703-9503-01 00703950301 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 0703-9503-03 00703950303 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-9503-03) / 5 mL in 1 VIAL, SINGLE-DOSE (0703-9503-01) 1991-11-01 0000-00-00 No No Current