Fingolimod Capsules

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:18:24

Label at a glance#

ProductFingolimod

Active ingredientFINGOLIMOD HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1603-3

Fingolimod Capsules, 0.5 mg

30 Capsules

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1012895	fingolimod 0.5 MG Oral Capsule	PSN	5
1012895	fingolimod 0.5 MG Oral Capsule	SCD	5
1012895	fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule	SY	5
1012895	fingolimod 500 MCG Oral Capsule	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
FINGOLIMOD Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1603-1	Fingolimod	100 in 1 BOTTLE	CAPSULE	100	5
70771-1603-3	Fingolimod	30 in 1 BOTTLE	CAPSULE	30	5
70771-1603-7	Fingolimod	7 in 1 BLISTER PACK	CAPSULE	7	5
70771-1603-7	Fingolimod	1 in 1 CARTON	CAPSULE	1	5
70771-1603-8	Fingolimod	7 in 1 BLISTER PACK	CAPSULE	7	5
70771-1603-8	Fingolimod	4 in 1 CARTON	CAPSULE	4	5
70771-1603-9	Fingolimod	90 in 1 BOTTLE	CAPSULE	90	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1603	FINGOLIMOD CAPSULE [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 7 package rows	20241201_5a0319b4-4bc6-4564-9687-9cfd5c1b23a8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Fingolimod
FINGOLIMOD HYDROCHLORIDE
ALCOHOL
AMMONIA
BUTYL ALCOHOL
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
STARCH, CORN
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1603	70771-1603-1, 70771-1603-7, 70771-1603-8, 70771-1603-3, 70771-1603-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FINGOLIMOD HYDROCHLORIDE	G926EC510T	ACTIM
ALCOHOL	3K9958V90M	IACT
AMMONIA	5138Q19F1X	IACT
BUTYL ALCOHOL	8PJ61P6TS3	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
GELATIN	2G86QN327L	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
POTASSIUM HYDROXIDE	WZH3C48M4T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STEARYL FUMARATE	7CV7WJK4UI	IACT
STARCH, CORN	O8232NY3SJ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A207994-001	FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB		2020-10-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A207994-001	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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-10-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-10-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-10-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-10-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-10-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-10-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2020-10-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207994-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2020-10-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207994-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207994-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207994-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207994-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207994-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207994-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207994-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207994-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207994-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207994-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207994-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207994-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207994-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207994-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207994-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207994-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207994-001	AB	1	`8072bd15b7f6…`
2021-03-12 10:30 UTC	2021-03	A207994-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207994-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207994-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207994-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207994-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207994-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207994-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207994-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207994-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207994-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207994-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207994-001	AB	1	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207994-001	AB	1	`a50c72e98297…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fingolimod	FINGOLIMOD	Zydus Lifesciences Limited	5a0319b4-4bc6-4564-9687-9cfd5c1b23a8	2024-11-30		Exact identifier ndc (package): 70771-1603-1 ndc (package): 70771-1603-3 ndc (package): 70771-1603-7 ndc (package): 70771-1603-8 ndc (package): 70771-1603-9 ndc (product): 70771-1603 ndc11 (package): 70771160308 ndc11 (package): 70771160301 ndc11 (package): 70771160303 ndc11 (package): 70771160309 ndc11 (package): 70771160307 spl id: 423dd0fd-c654-4de1-b535-947cd795758b spl set id: 5a0319b4-4bc6-4564-9687-9cfd5c1b23a8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.