Dalfampridine

Product NDC: 16729-292
11-digit product format: 167290292
Labeler code: 16729
Product ID: 16729-292_40bc3607-8ee1-5a56-e063-6294a90a3b3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dalfampridine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA206863
Marketing category: ANDA
Marketing start: 2018-09-18
Substance: DALFAMPRIDINE
Active strength: 10 mg/1
Pharmacologic classes: Potassium Channel Antagonists [MoA], Potassium Channel Blocker [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
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 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206863-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-11	`3a93d1ddd44b…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	A206863-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206863-001	AB	1	`e64feba35796…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dalfampridine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DALFAMPRIDINE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BH3B64OKL9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
897021	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
354a97e8-35c8-418b-91b2-9e8e066cec65	Available on FDA.report

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	SPL version
16729-292-01	Dalfampridine	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	8
16729-292-10	Dalfampridine	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	8
16729-292-12	Dalfampridine	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	8
16729-292-16	Dalfampridine	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	8
16729-292-17	Dalfampridine	1000 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	1000	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-292-12	EA - Each	16729-292	dd5d33c9-fb5a-43ab-a03a-8976b2c8d1d4	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-292	DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]	7	Current NDC, Legacy NDC, 5 package rows	20240105_354a97e8-35c8-418b-91b2-9e8e066cec65.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 ndc (product): 16729-292

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
897021	dalfampridine 10 MG 12HR Extended Release Oral Tablet	PSN	354a97e8-35c8-418b-91b2-9e8e066cec65	8
897021	12 HR dalfampridine 10 MG Extended Release Oral Tablet	SCD	354a97e8-35c8-418b-91b2-9e8e066cec65	8
897021	dalfampridine 10 MG 12 HR Extended Release Oral Tablet	SY	354a97e8-35c8-418b-91b2-9e8e066cec65	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-292-01	16729029201	100 in 1 BOTTLE					Historical
16729-292-10	16729029210	30 in 1 BOTTLE					Historical
16729-292-12	16729029212	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16729-292-12)	2018-09-18	0000-00-00	No	No	Current
16729-292-16	16729029216	500 in 1 BOTTLE					Historical
16729-292-17	16729029217	1000 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dalfampridine	Golden State Medical Supply, Inc.	2025-11-25	HUMAN PRESCRIPTION DRUG LABEL	7
Dalfampridine	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	8