Home NDC 64980-449-97 fingolimod
Product NDC 64980-449
Requested package NDC 64980-449-97
11-digit product format 649800449
Labeler code 64980
Product ID 64980-449_2622c15a-3781-3016-e063-6294a90a84d5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fingolimod hcl
Dosage form CAPSULE
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA207939
Marketing category ANDA
Marketing start 2021-11-10
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A207939-001 FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207939-001 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 2026-02-19 14:30 UTC 2026-02 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2019-12-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2019-12-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2019-12-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2019-12-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2019-12-04 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207939-001 FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2021-11-10 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base fingolimod
Listing expiration 2026-12-31 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 64980-449-03 fingolimod 30 in 1 BOTTLE CAPSULE 30 17 64980-449-07 fingolimod 7 in 1 CARTON CAPSULE 7 17 64980-449-28 fingolimod 28 in 1 CARTON CAPSULE 28 17 64980-449-97 fingolimod 7 in 1 BLISTER PACK CAPSULE 7 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-449 FINGOLIMOD (FINGOLIMOD HCL) CAPSULE [RISING PHARMA HOLDINGS, INC.] 17 Current NDC, Legacy NDC, 4 package rows 20241106_99e7daf4-ea90-5e47-e053-2a95a90ac1b7.zip
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 Marketing end Sample Exclude flag Status 64980-449-97 64980044997 7 CAPSULE in 1 BLISTER PACK (64980-449-97) 7 capsule 2021-01-01 0000-00-00 No No Current