Home NDC 63187-008 Sulfamethoxazole and Trimethoprim
Product NDC 63187-008
11-digit product format 631870008
Labeler code 63187
Product ID 63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA076817
Marketing category ANDA
Marketing start 2006-08-22
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07
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 · 84 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 2026-08-18 06:07:40 2026-07 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076817-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2005-10-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076817-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2005-10-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 · 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 63187-008-06 Sulfamethoxazole and Trimethoprim 6 in 1 BOTTLE TABLET 6 8 63187-008-10 Sulfamethoxazole and Trimethoprim 10 in 1 BOTTLE TABLET 10 8 63187-008-14 Sulfamethoxazole and Trimethoprim 14 in 1 BOTTLE TABLET 14 8 63187-008-20 Sulfamethoxazole and Trimethoprim 20 in 1 BOTTLE TABLET 20 8 63187-008-28 Sulfamethoxazole and Trimethoprim 28 in 1 BOTTLE TABLET 28 8 63187-008-40 Sulfamethoxazole and Trimethoprim 40 in 1 BOTTLE TABLET 40 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-008 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PROFICIENT RX LP] 8 Current NDC, Legacy NDC, 6 package rows 20221018_c407381f-3d8e-4fdf-9132-cd3968099296.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 63187-008-06 63187000806 6 TABLET in 1 BOTTLE (63187-008-06) 6 tablet 2018-11-01 0000-00-00 No No Current 63187-008-10 63187000810 10 TABLET in 1 BOTTLE (63187-008-10) 10 tablet 2018-11-01 0000-00-00 No No Current 63187-008-14 63187000814 14 TABLET in 1 BOTTLE (63187-008-14) 14 tablet 2018-11-01 0000-00-00 No No Current 63187-008-20 63187000820 20 TABLET in 1 BOTTLE (63187-008-20) 20 tablet 2018-11-01 0000-00-00 No No Current 63187-008-28 63187000828 28 TABLET in 1 BOTTLE (63187-008-28) 28 tablet 2018-11-01 0000-00-00 No No Current 63187-008-40 63187000840 40 TABLET in 1 BOTTLE (63187-008-40) 40 tablet 2018-11-01 0000-00-00 No No Current