Home NDC 11534-200 Sulfasalazine
Product NDC 11534-200
11-digit product format 115340200
Labeler code 11534
Product ID 11534-200_97b74888-4b28-4f9a-b5b9-64d23bc7e808
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfasalazine
Dosage form TABLET
Route ORAL
Labeler Sunrise Pharmaceutical, Inc.
Application ANDA040349
Marketing category ANDA
Marketing start 2025-07-15
Substance SULFASALAZINE
Active strength 500 mg/1
Pharmacologic classes Aminosalicylate [EPC], Aminosalicylic Acids [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 1 .
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 A040349-001 SULFASALAZINE SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040349-001 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 · 41 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 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sulfasalazine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFASALAZINE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3XC8GUZ6CB Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198232 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 11534-200-01 Sulfasalazine 100 in 1 BOTTLE TABLET 100 4 11534-200-04 Sulfasalazine 500 in 1 BOTTLE TABLET 500 4 11534-200-07 Sulfasalazine 300 in 1 BOTTLE TABLET 300 4
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11534-200-01 11534020001 100 TABLET in 1 BOTTLE (11534-200-01) 100 tablet 2025-07-15 No No Current 11534-200-04 11534020004 500 TABLET in 1 BOTTLE (11534-200-04) 500 tablet 2025-07-15 No No Current 11534-200-07 11534020007 300 TABLET in 1 BOTTLE (11534-200-07) 300 tablet 2025-07-15 No No Current