FINGOLIMOD

Product NDC: 82009-143
11-digit product format: 820090143
Labeler code: 82009
Product ID: 82009-143_c10504a7-d1e3-b3d2-2b35-43f1e602d8c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FINGOLIMOD
Dosage form: CAPSULE
Route: ORAL
Labeler: Quallent Pharmaceuticals Health LLC
Application: ANDA207979
Marketing category: ANDA
Marketing start: 2024-03-28
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: 2026-12-31
Current FDA listing: Yes

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
A207979-001	FINGOLIMOD HYDROCHLORIDE	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB		2019-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207979-001	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
2026-02-19 14:30 UTC	2026-02	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207979-001	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	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL		2019-12-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207979-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207979-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207979-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207979-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207979-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207979-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207979-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207979-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207979-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207979-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207979-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207979-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207979-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207979-001	AB	1	`8072bd15b7f6…`
2019-12-14 00:12 UTC	2019-12	A207979-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207979-001	AB	1	`6a51e52b5d6a…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207979-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207979-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207979-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207979-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FINGOLIMOD	FINGOLIMOD	Quallent Pharmaceuticals Health LLC	5434bd4a-2610-0e17-4f14-513ff1cbb822	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207979 application number: ANDA207979 ndc (product): 82009-143
FINGOLIMOD	FINGOLIMOD	Biocon Pharma Inc.	550a5fa3-94a4-0b55-9cb5-c0178acfe319	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207979 application number: ANDA207979

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5434bd4a-2610-0e17-4f14-513ff1cbb822	Available on FDA.report

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	Strength	SPL version
82009-143-30	FINGOLIMOD	30 in 1 BOTTLE	CAPSULE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82009-143-30	EA - Each	82009-143	e0fe8c48-de80-4b26-9e93-f71ec0db35d6	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82009-143	FINGOLIMOD CAPSULE [QUALLENT PHARMACEUTICALS HEALTH LLC]	2	Current NDC, 1 package rows	20250302_5434bd4a-2610-0e17-4f14-513ff1cbb822.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1012895	fingolimod 0.5 MG Oral Capsule	PSN	5434bd4a-2610-0e17-4f14-513ff1cbb822	3
1012895	fingolimod 0.5 MG Oral Capsule	SCD	5434bd4a-2610-0e17-4f14-513ff1cbb822	3
1012895	fingolimod 0.5 MG (as fingolimod HCl 0.56 MG) Oral Capsule	SY	5434bd4a-2610-0e17-4f14-513ff1cbb822	3
1012895	fingolimod 500 MCG Oral Capsule	SY	5434bd4a-2610-0e17-4f14-513ff1cbb822	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82009-143-30	82009014330	30 CAPSULE in 1 BOTTLE (82009-143-30)	30 capsule	2024-03-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FINGOLIMOD	Quallent Pharmaceuticals Health LLC \| Biocon Limited \| Biocon Pharma Limited	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	4