Home NDC 60429-259-05 Sulfamethoxazole and Trimethoprim
Product NDC 60429-259
Requested package NDC 60429-259-05
11-digit product format 604290259
Labeler code 60429
Product ID 60429-259_36efef59-2b05-db1b-e063-6394a90af8ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA071017
Marketing category ANDA
Marketing start 1986-08-25
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 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…2022-03-09 01:35 UTC 2022-03 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 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 · 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 60429-259-01 Sulfamethoxazole and Trimethoprim 100 in 1 BOTTLE, PLASTIC TABLET 100 12 60429-259-05 Sulfamethoxazole and Trimethoprim 500 in 1 BOTTLE, PLASTIC TABLET 500 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 60429-259 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20241027_bd3161fe-23d7-458a-86a4-fb958d9c94d3.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 60429-259-05 60429025905 500 TABLET in 1 BOTTLE, PLASTIC (60429-259-05) 500 tablet 2015-04-24 0000-00-00 No No Current