Home NDC 63629-9715 Sulfasalazine
Product NDC 63629-9715
11-digit product format 636299715
Labeler code 63629
Product ID 63629-9715_00104d3b-3b62-49fb-8a04-26ec7c24efcc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfasalazine
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA085828
Marketing category ANDA
Marketing start 2022-12-15
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 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.
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 63629-9715-1 Sulfasalazine 90 in 1 BOTTLE, PLASTIC TABLET 90 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-9715 SULFASALAZINE TABLET [BRYANT RANCH PREPACK] 101 Current NDC, 1 package rows 20240509_618c5324-d0a6-4d00-9b12-0de88a71c180.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63629-9715-1 63629971501 90 TABLET in 1 BOTTLE, PLASTIC (63629-9715-1) 90 tablet 2023-06-22 No No Current