DALFAMPRIDINE

Product NDC: 42571-275
11-digit product format: 425710275
Labeler code: 42571
Product ID: 42571-275_3afc3c42-1157-b612-e063-6294a90ac179
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DALFAMPRIDINE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA210158
Marketing category: ANDA
Marketing start: 2019-03-21
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
A210158-001	DALFAMPRIDINE	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210158-001	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	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210158-001	DALFAMPRIDINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-03-11	`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	A210158-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210158-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210158-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210158-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210158-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210158-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210158-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210158-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210158-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210158-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210158-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210158-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210158-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210158-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210158-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210158-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210158-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210158-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210158-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210158-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210158-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210158-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210158-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210158-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210158-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210158-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210158-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210158-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210158-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210158-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210158-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210158-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210158-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210158-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210158-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210158-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210158-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210158-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210158-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210158-001	AB	1	`e64feba35796…`

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
302c8270-4711-4ca4-bee8-be0738fbe094	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
42571-275-05	DALFAMPRIDINE	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	9
42571-275-10	DALFAMPRIDINE	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	9
42571-275-60	DALFAMPRIDINE	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-275-60	EA - Each	42571-275	21442cf8-834c-4ec7-9320-9a66c1674eeb	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-275	DALFAMPRIDINE TABLET, EXTENDED RELEASE [MICRO LABS LIMITED]	8	Current NDC, Legacy NDC, 3 package rows	20221128_302c8270-4711-4ca4-bee8-be0738fbe094.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
DALFAMPRIDINE	DALFAMPRIDINE	Micro Labs Limited	302c8270-4711-4ca4-bee8-be0738fbe094	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210158 application number: ANDA210158 ndc (product): 42571-275
DALFAMPRIDINE	DALFAMPRIDINE	Bryant Ranch Prepack	688eb479-debc-4cfc-a74d-14828c347049	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210158 application number: ANDA210158

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	688eb479-debc-4cfc-a74d-14828c347049	100
897021	12 HR dalfampridine 10 MG Extended Release Oral Tablet	SCD	688eb479-debc-4cfc-a74d-14828c347049	100
897021	dalfampridine 10 MG 12 HR Extended Release Oral Tablet	SY	688eb479-debc-4cfc-a74d-14828c347049	100
897021	dalfampridine 10 MG 12HR Extended Release Oral Tablet	PSN	302c8270-4711-4ca4-bee8-be0738fbe094	9
897021	12 HR dalfampridine 10 MG Extended Release Oral Tablet	SCD	302c8270-4711-4ca4-bee8-be0738fbe094	9
897021	dalfampridine 10 MG 12 HR Extended Release Oral Tablet	SY	302c8270-4711-4ca4-bee8-be0738fbe094	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-275-05	42571027505	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05)	2019-03-21	0000-00-00	No	No	Current
42571-275-10	42571027510	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10)	2019-03-21	0000-00-00	No	No	Current
42571-275-60	42571027560	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-60)	2019-03-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DALFAMPRIDINE	Micro Labs Limited	2025-07-28	HUMAN PRESCRIPTION DRUG LABEL	9
DALFAMPRIDINE	Bryant Ranch Prepack	2025-02-12	HUMAN PRESCRIPTION DRUG LABEL	100