Home NDC 16571-261 Sulfasalazine
Product NDC 16571-261
11-digit product format 165710261
Labeler code 16571
Product ID 16571-261_4b43540c-2b08-44cb-81b8-4308dea2c141
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfasalazine
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA219046
Marketing category ANDA
Marketing start 2025-11-04
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 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 A219046-001 SULFASALAZINE SULFASALAZINE 500MG TABLET / ORAL AB 2025-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219046-001 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 2026-08-18 06:07:40 2026-07 A219046-001 SULFASALAZINE 500MG TABLET / ORAL AB 2025-11-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219046-001 SULFASALAZINE 500MG TABLET / ORAL AB 2025-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219046-001 SULFASALAZINE 500MG TABLET / ORAL AB 2025-11-04 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219046-001 SULFASALAZINE 500MG TABLET / ORAL AB 2025-11-04 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A219046-001 AB 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219046-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219046-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219046-001 AB 1 a50c72e98297…
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 16571-261-01 Sulfasalazine 100 in 1 CONTAINER TABLET 100 1 16571-261-30 Sulfasalazine 300 in 1 CONTAINER TABLET 300 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# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 16571-261-01 16571026101 100 TABLET in 1 CONTAINER (16571-261-01) 100 tablet 2025-11-04 No No Current 16571-261-30 16571026130 300 TABLET in 1 CONTAINER (16571-261-30) 300 tablet 2025-11-04 No No Current