Dalfampridine

Product NDC: 51407-246
11-digit product format: 514070246
Labeler code: 51407
Product ID: 51407-246_e07ecff3-ff2e-c868-e053-2a95a90aa9f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dalfampridine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA206863
Marketing category: ANDA
Marketing start: 2018-07-11
Marketing end: 0000-00-00
Substance: DALFAMPRIDINE
Active strength: 10 mg/1
Pharmacologic classes: Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51407-246		D	Discontinued by firm		2026-10-21
excluded package	package	51407-246	51407-246-60	D	Discontinued by firm		2026-10-21

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
A206863-001	DALFAMPRIDINE	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206863-001	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.

Product history page 2 of 2 · 44 observed 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
2022-10-28 04:53 UTC	2022-10	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A206863-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A206863-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206863-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206863-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206863-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206863-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206863-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206863-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206863-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206863-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206863-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206863-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206863-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206863-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206863-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206863-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206863-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206863-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206863-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206863-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206863-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206863-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206863-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206863-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206863-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206863-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206863-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206863-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206863-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206863-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206863-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206863-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206863-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206863-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206863-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206863-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206863-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206863-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206863-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206863-001	AB	1	`3a93d1ddd44b…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A206863-001	PC	2019-03-09	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A206863-001	PC	2019-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206863-001	PC	2019-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206863-001	PC	2019-03-09	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9109832c-cb3c-b72f-db80-0e6688f08431	Product name	5	20190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51407-246-60	Dalfampridine	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-246-60	EA - Each	51407-246	6a1f3d93-6724-4f2b-962f-428fe2253fc0	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-246	DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]	6	Legacy NDC, 1 package rows	20240302_9b301b27-a182-63d0-e053-2a95a90a10d7.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dalfampridine	DALFAMPRIDINE	Accord Healthcare Inc.	354a97e8-35c8-418b-91b2-9e8e066cec65	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206863 application number: ANDA206863

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BH3B64OKL9	DALFAMPRIDINE	504-24-5	DALFAMPRIDINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-246-60	51407024660	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (51407-246-60)	2019-12-23	0000-00-00	No	No	Current