Home NDC 62332-228 Fingolimod
Product NDC 62332-228
11-digit product format 623320228
Labeler code 62332
Product ID 62332-228_a4c261a5-8b05-41d7-864b-c9de27c594dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fingolimod
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA207974
Marketing category ANDA
Marketing start 2026-04-28
Substance FINGOLIMOD HYDROCHLORIDE
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 2027-12-31
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 A207974-001 FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2026-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207974-001 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 A207974-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2026-04-24 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207974-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2026-04-24 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 A207974-001 AB 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207974-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Fingolimod
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FINGOLIMOD HYDROCHLORIDE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G926EC510T 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 62332-228-10 Fingolimod 100 in 1 CARTON CAPSULE 100 10 62332-228-10 Fingolimod 10 in 1 BLISTER PACK CAPSULE 10 10 62332-228-30 Fingolimod 30 in 1 BOTTLE CAPSULE 30 10
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 · 2 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 62332-228-10 62332022810 100 BLISTER PACK in 1 CARTON (62332-228-10) / 10 CAPSULE in 1 BLISTER PACK 100 blister pack 2026-04-28 No No Current 62332-228-30 62332022830 30 CAPSULE in 1 BOTTLE (62332-228-30) 30 capsule 2026-04-28 No No Current