Home NDC 0591-0796-01 Sulfasalazine
Product NDC 0591-0796
Requested package NDC 0591-0796-01
11-digit product format 005910796
Labeler code 0591
Product ID 0591-0796_9174d15c-8a8b-4a9b-9ef2-f38b25a3ccb6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfasalazine
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA085828
Marketing category ANDA
Marketing start 1982-10-01
Marketing end 0000-00-00
Substance SULFASALAZINE
Active strength 500 mg/1
Pharmacologic classes Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A085828-001 SULFASALAZINE SULFASALAZINE 500MG TABLET / ORAL AB Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A085828-001 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.
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 2026-08-01 22:54:32 2026-06 A085828-001 SULFASALAZINE 500MG TABLET / ORAL AB Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A085828-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFASALAZINE ACTIVE INGREDIENT 3XC8GUZ6CB SULFASALAZINE TABLET [WATSON LABORATORIES, INC.] 9 SULFASALAZINE ACTIVE MOIETY 3XC8GUZ6CB SULFASALAZINE TABLET [WATSON LABORATORIES, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULFASALAZINE TABLET [WATSON LABORATORIES, INC.] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SULFASALAZINE TABLET [WATSON LABORATORIES, INC.] 9 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULFASALAZINE TABLET [WATSON LABORATORIES, INC.] 9 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SULFASALAZINE TABLET [WATSON LABORATORIES, INC.] 9 SULFASALAZINE ACTIVE INGREDIENT 3XC8GUZ6CB SULFASALAZINE (SULFASALAZINE) TABLET [AVPAK] 2 SULFASALAZINE ACTIVE MOIETY 3XC8GUZ6CB SULFASALAZINE (SULFASALAZINE) TABLET [AVPAK] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULFASALAZINE (SULFASALAZINE) TABLET [AVPAK] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SULFASALAZINE (SULFASALAZINE) TABLET [AVPAK] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULFASALAZINE (SULFASALAZINE) TABLET [AVPAK] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SULFASALAZINE (SULFASALAZINE) TABLET [AVPAK] 2 SULFASALAZINE ACTIVE INGREDIENT 3XC8GUZ6CB SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] 1 SULFASALAZINE ACTIVE MOIETY 3XC8GUZ6CB SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] 1 SODIUM STEAROYL LACTYLATE INACTIVE INGREDIENT IN99IT31LN SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULFASALAZINE TABLET [PREFERRED PHARMACEUTICALS, INC] 1
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 0591-0796-01 00591079601 100 TABLET in 1 BOTTLE, PLASTIC (0591-0796-01) 100 tablet 1982-10-01 2024-11-30 No No Current