Home NDC 70518-2604-5 Sulfamethoxazole and Trimethoprim
Product NDC 70518-2604
Requested package NDC 70518-2604-5
11-digit product format 705182604
Labeler code 70518
Product ID 70518-2604_579aa2c0-81f5-dd0a-e063-6294a90a23cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA090624
Marketing category ANDA
Marketing start 2020-02-28
Substance SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength 800; 160 mg/1; mg/1
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 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 88 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 2026-10-15 13:18:30 2026-09 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090624-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2010-02-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090624-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2010-02-16 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFAMETHOXAZOLE 800 mg/1 TRIMETHOPRIM 160 mg/1
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 198335 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 70518-2604-0 Sulfamethoxazole and Trimethoprim 14 in 1 BOTTLE, PLASTIC TABLET 14 25 70518-2604-1 Sulfamethoxazole and Trimethoprim 20 in 1 BOTTLE, PLASTIC TABLET 20 25 70518-2604-2 Sulfamethoxazole and Trimethoprim 6 in 1 BOTTLE, PLASTIC TABLET 6 25 70518-2604-3 Sulfamethoxazole and Trimethoprim 14 in 1 BLISTER PACK TABLET 14 25 70518-2604-4 Sulfamethoxazole and Trimethoprim 20 in 1 BOTTLE, PLASTIC TABLET 20 25 70518-2604-5 Sulfamethoxazole and Trimethoprim 30 in 1 BLISTER PACK TABLET 30 25 70518-2604-6 Sulfamethoxazole and Trimethoprim 20 in 1 BLISTER PACK TABLET 20 25 70518-2604-7 Sulfamethoxazole and Trimethoprim 21 in 1 BOTTLE, PLASTIC TABLET 21 25 70518-2604-8 Sulfamethoxazole and Trimethoprim 14 in 1 BOTTLE, PLASTIC TABLET 14 25 70518-2604-9 Sulfamethoxazole and Trimethoprim 10 in 1 BOTTLE, PLASTIC TABLET 10 25
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-2604 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REMEDYREPACK INC.] 22 Current NDC, Legacy NDC, 10 package rows 20250202_c45ac3a4-d397-486e-abd1-349916543068.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 3 of 3 · 45 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 70518-2604-5 70518260405 30 TABLET in 1 BLISTER PACK (70518-2604-5) 30 tablet 2022-03-17 0000-00-00 No No Current