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 42.

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
2026-08-18 06:07:40	2026-07	A207979-001	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	2019-12-04	`caaa826d4ba7…`
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
2026-08-18 06:07:40	2026-07	A207979-001	AB	1	`caaa826d4ba7…`
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…`

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

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.

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

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