Fingolimod

Product NDC: 0378-4525
Requested package NDC: 0378-4525-93
11-digit product format: 003784525
Labeler code: 0378
Product ID: 0378-4525_3f9827b7-f7b0-4c5a-a53d-b08641d45beb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fingolimod
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA208005
Marketing category: ANDA
Marketing start: 2022-09-22
Marketing end: 0000-00-00
Substance: FINGOLIMOD HYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Sphingosine 1-Phosphate Receptor Modulators [MoA], Sphingosine 1-phosphate Receptor Modulator [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0378-4525	0378-4525-93	D	Discontinued by firm		2026-07-31

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
A208005-001	FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL			2021-01-19

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	A208005-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL			2021-01-19	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
665f4aef-df96-42b3-97d1-5971737de3dc	Product name	9	20250121
6b6bc7ea-a5a8-4e5e-b81d-4b6b4cbe6f45	Product name	1	20230919
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4525-93	EA - Each	0378-4525	e70e8aaf-9102-463d-b7d4-dd93d105bcab	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-4525	FINGOLIMOD CAPSULE [MYLAN PHARMACEUTICALS INC.]	6	Legacy NDC	20250316_3f9827b7-f7b0-4c5a-a53d-b08641d45beb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G926EC510T	FINGOLIMOD HYDROCHLORIDE	162359-56-0	FINGOLIMOD HYDROCHLORIDE
3QN8BYN5QF	FINGOLIMOD	162359-55-9	Fingolimod

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-4525-93	00378452593	30 CAPSULE in 1 BOTTLE, PLASTIC (0378-4525-93)	30 capsule	2022-09-22	0000-00-00	No	No	Current