Home NDC 82249-385 Fingolimod
Product NDC 82249-385
11-digit product format 822490385
Labeler code 82249
Product ID 82249-385_e1960f9b-f739-452c-b167-245551bf3690
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fingolimod
Dosage form CAPSULE
Route ORAL
Labeler CivicaScript LLC
Application ANDA208004
Marketing category ANDA
Marketing start 2026-06-01
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 43 .
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 A208004-001 FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208004-001 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 2026-09-14 22:38:34 2026-08 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2020-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2020-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2020-12-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2020-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2020-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2020-12-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2020-12-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208004-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2020-12-30 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82249-385-30 82249038530 30 CAPSULE in 1 BOTTLE (82249-385-30) 30 capsule 2026-06-01 No No Current