Home NDC 17856-0496 Sulfamethoxazole and Trimethoprim
Product NDC 17856-0496
11-digit product format 178560496
Labeler code 17856
Product ID 17856-0496_361f7b6e-a67d-c21a-e063-6394a90ad8ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form SUSPENSION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA091348
Marketing category ANDA
Marketing start 2017-10-04
Substance SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength 200; 40 mg/5mL; mg/5mL
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 17856-0496-6 excluded package package 17856-0496-4 excluded package package 17856-0496-5
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091348-001 AB
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 · 42 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 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 2010-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091348-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2010-06-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 200 mg/5mL TRIMETHOPRIM 40 mg/5mL
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 313134 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 17856-0496-4 2024-04-12 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-4 2024-04-12 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-5 2024-04-12 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-5 2024-04-12 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-6 2024-04-12 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-6 2024-04-12 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-4 2024-01-30 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-4 2024-01-30 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-5 2024-01-30 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-5 2024-01-30 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-6 2024-01-30 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-6 2024-01-30 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-1 2021-08-27 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-1 2021-08-27 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-2 2021-08-27 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-2 2021-08-27 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-3 2021-08-27 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-3 2021-08-27 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-1 2021-01-29 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-1 2021-01-29 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-2 2021-01-29 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-2 2021-01-29 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-3 2021-01-29 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only 17856-0496-3 2021-01-29 Sulfamethoxazole and Trimethoprim Oral Suspension, USP Rx only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0496-1 Sulfamethoxazole and Trimethoprim 5 mL in 1 CUP, UNIT-DOSE SUSPENSION 5 7 17856-0496-2 Sulfamethoxazole and Trimethoprim 10 mL in 1 CUP, UNIT-DOSE SUSPENSION 10 7 17856-0496-3 Sulfamethoxazole and Trimethoprim 20 mL in 1 CUP, UNIT-DOSE SUSPENSION 20 7 17856-0496-4 Sulfamethoxazole and Trimethoprim 72 in 1 BOX SUSPENSION 72 7 17856-0496-5 Sulfamethoxazole and Trimethoprim 50 in 1 BOX SUSPENSION 50 7 17856-0496-6 Sulfamethoxazole and Trimethoprim 72 in 1 BOX SUSPENSION 72 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0496 SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORP.] 7 Current NDC, Legacy NDC, 6 package rows 20250529_acc3df02-1e99-46e6-8a31-9b26261c6daa.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 · 4 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 17856-0496-1 17856049601 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1) 5 ml 2021-08-27 0000-00-00 No No Current 17856-0496-2 17856049602 10 mL in 1 CUP, UNIT-DOSE (17856-0496-2) 10 ml 2021-08-27 0000-00-00 No No Current 17856-0496-3 17856049603 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3) 20 ml 2021-08-27 0000-00-00 No No Current 17856-0496-4 17856049604 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-4) / 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1) 2024-04-12 0000-00-00 No No Current 17856-0496-5 17856049605 50 CUP, UNIT-DOSE in 1 BOX (17856-0496-5) / 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3) 2024-04-12 0000-00-00 No No Current 17856-0496-6 17856049606 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-6) / 10 mL in 1 CUP, UNIT-DOSE (17856-0496-2) 2024-04-12 0000-00-00 No No Current 17856-0496-7 17856049607 48 SYRINGE in 1 CASE (17856-0496-7) / 5 mL in 1 SYRINGE 48 syringe 2026-08-05 0 Current 17856-0496-8 17856049608 48 SYRINGE in 1 CASE (17856-0496-8) / 10 mL in 1 SYRINGE 48 syringe 2026-08-05 0 Current