Home NDC 0603-5801 Sulfasalazine
Product NDC 0603-5801
11-digit product format 006035801
Labeler code 0603
Product ID 0603-5801_6706375c-9731-4dc7-b777-1459079a6419
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulfasalazine
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical
Application ANDA040349
Marketing category ANDA
Marketing start 2002-01-11
Marketing end 2019-07-31
Substance SULFASALAZINE
Active strength 500 mg/1
Pharmacologic classes Aminosalicylate [EPC],Aminosalicylic Acids [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040349-001 SULFASALAZINE 500MG TABLET / ORAL AB 2002-01-11 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A040349-001 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040349-001 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040349-001 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A040349-001 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFASALAZINE ACTIVE INGREDIENT 3XC8GUZ6CB SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.] 1 SULFASALAZINE ACTIVE INGREDIENT 3XC8GUZ6CB SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 SULFASALAZINE ACTIVE MOIETY 3XC8GUZ6CB SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.] 1 SULFASALAZINE ACTIVE MOIETY 3XC8GUZ6CB SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SULFASALAZINE TABLET [BLENHEIM PHARMACAL, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SULFASALAZINE TABLET [AIDAREX PHARMACEUTICALS LLC] 1
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#