Home NDC 43547-003 FINGOLIMOD
Product NDC 43547-003
11-digit product format 435470003
Labeler code 43547
Product ID 43547-003_8a52d7dc-58d1-4dec-bfbd-5424ec30b984
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fingolimod
Dosage form CAPSULE
Route ORAL
Labeler Solco Healthcare US, LLC
Application ANDA208003
Marketing category ANDA
Marketing start 2020-02-17
Substance FINGOLIMOD
Active strength .5 mg/1
Pharmacologic classes Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
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 A208003-001 FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2022-09-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208003-001 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 A208003-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2022-09-07 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 A208003-001 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base FINGOLIMOD
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FINGOLIMOD .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3QN8BYN5QF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012895 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 43547-003-03 FINGOLIMOD 30 in 1 BOTTLE CAPSULE 30 2 43547-003-09 FINGOLIMOD 90 in 1 BOTTLE CAPSULE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43547-003 FINGOLIMOD CAPSULE [SOLCO HEALTHCARE US, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20240927_6c0faf2b-21fb-4830-bb78-5f2dbceb2c82.zip
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 43547-003-03 43547000303 30 CAPSULE in 1 BOTTLE (43547-003-03) 30 capsule 2021-10-26 0000-00-00 No No Current 43547-003-09 43547000309 90 CAPSULE in 1 BOTTLE (43547-003-09) 90 capsule 2021-10-26 0000-00-00 No No Current