Home NDC 53489-145-01 Sulfamethoxazole and Trimethoprim
Product NDC 53489-145
Requested package NDC 53489-145-01
11-digit product format 534890145
Labeler code 53489
Product ID 53489-145_31dd7abe-e7f2-10df-e063-6394a90a93e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA071017
Marketing category ANDA
Marketing start 1986-08-25
Substance SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength 400; 80 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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25
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 · 86 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 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 400 mg/1 TRIMETHOPRIM 80 mg/1
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 198334 Internal RxNorm lookup 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 53489-145-01 Sulfamethoxazole and Trimethoprim 100 in 1 BOTTLE, PLASTIC TABLET 100 19 53489-145-05 Sulfamethoxazole and Trimethoprim 500 in 1 BOTTLE, PLASTIC TABLET 500 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sulfamethoxazole ACTIVE INGREDIENT JE42381TNV SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 8 Trimethoprim ACTIVE INGREDIENT AN164J8Y0X SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 8 Sulfamethoxazole ACTIVE MOIETY JE42381TNV SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 8 Trimethoprim ACTIVE MOIETY AN164J8Y0X SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 8 Docusate sodium INACTIVE INGREDIENT F05Q2T2JA0 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 8 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 8 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 8 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 8 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 8 Sulfamethoxazole ACTIVE INGREDIENT JE42381TNV SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 Trimethoprim ACTIVE INGREDIENT AN164J8Y0X SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 Sulfamethoxazole ACTIVE MOIETY JE42381TNV SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 Trimethoprim ACTIVE MOIETY AN164J8Y0X SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 Docusate sodium INACTIVE INGREDIENT F05Q2T2JA0 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53489-145 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20250406_4833319a-a7b3-4bf4-bec4-6531b43182d4.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 · 2 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 53489-145-01 53489014501 100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01) 100 tablet 1986-08-25 0000-00-00 No No Current