Firdapse

Product NDC: 69616-211
11-digit product format: 696160211
Labeler code: 69616
Product ID: 69616-211_4f94edd2-b6a8-264d-e063-6294a90a89df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amifampridine phosphate
Dosage form: TABLET
Route: ORAL
Labeler: Catalyst Pharmaceuticals, Inc.
Application: NDA208078
Marketing category: NDA
Marketing start: 2019-01-07
Substance: AMIFAMPRIDINE PHOSPHATE
Active strength: 10 mg/1
Pharmacologic classes: Potassium Channel Antagonists [MoA], Potassium Channel Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
N208078-001	FIRDAPSE	AMIFAMPRIDINE PHOSPHATE	EQ 10MG BASE	TABLET / ORAL		RLD, RS	2018-11-28

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208078-001	11060128	2032-06-29	U-2956		2021-07-19
N208078-001	11268128	2032-06-29	U-2956		2022-03-10
N208078-001	11274331	2032-06-29	U-2956		2022-03-30
N208078-001	11274332	2032-06-29	U-2956		2022-03-30
N208078-001	10793893	2034-05-26	U-2956		2020-10-07
N208078-001	10626088	2037-02-25		Drug product	2022-08-09

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208078-001	ODE-553	2029-09-29

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208078-001	FIRDAPSE	EQ 10MG BASE	TABLET / ORAL	RLD, RS	2018-11-28	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 193 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208078-001	11060128	2032-06-29	U-2956		2021-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208078-001	11268128	2032-06-29	U-2956		2022-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208078-001	11274331	2032-06-29	U-2956		2022-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208078-001	11274332	2032-06-29	U-2956		2022-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208078-001	10793893	2034-05-26	U-2956		2020-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208078-001	10626088	2037-02-25		Drug product	2022-08-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208078-001	11060128	2032-06-29	U-2956		2021-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208078-001	11268128	2032-06-29	U-2956		2022-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208078-001	11274331	2032-06-29	U-2956		2022-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208078-001	11274332	2032-06-29	U-2956		2022-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208078-001	10793893	2034-05-26	U-2956		2020-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208078-001	10626088	2037-02-25		Drug product	2022-08-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208078-001	11060128	2032-06-29	U-2956		2021-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208078-001	11268128	2032-06-29	U-2956		2022-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208078-001	11274331	2032-06-29	U-2956		2022-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208078-001	11274332	2032-06-29	U-2956		2022-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208078-001	10793893	2034-05-26	U-2956		2020-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208078-001	10626088	2037-02-25		Drug product	2022-08-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208078-001	11060128	2032-06-29	U-2956		2021-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208078-001	11268128	2032-06-29	U-2956		2022-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208078-001	11274331	2032-06-29	U-2956		2022-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208078-001	11274332	2032-06-29	U-2956		2022-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208078-001	10793893	2034-05-26	U-2956		2020-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208078-001	10626088	2037-02-25		Drug product	2022-08-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208078-001	11060128	2032-06-29	U-2956		2021-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208078-001	11268128	2032-06-29	U-2956		2022-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208078-001	11274331	2032-06-29	U-2956		2022-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208078-001	11274332	2032-06-29	U-2956		2022-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208078-001	10793893	2034-05-26	U-2956		2020-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208078-001	10626088	2037-02-25		Drug product	2022-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208078-001	11060128	2032-06-29	U-2956		2021-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208078-001	11268128	2032-06-29	U-2956		2022-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208078-001	11274331	2032-06-29	U-2956		2022-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208078-001	11274332	2032-06-29	U-2956		2022-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208078-001	10793893	2034-05-26	U-2956		2020-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208078-001	10626088	2037-02-25		Drug product	2022-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208078-001	11060128	2032-06-29	U-2956		2021-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208078-001	11268128	2032-06-29	U-2956		2022-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208078-001	11274331	2032-06-29	U-2956		2022-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208078-001	11274332	2032-06-29	U-2956		2022-03-30	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N208078-001	ODE-553	2029-09-29	`caaa826d4ba7…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208078-001	NPP	2025-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208078-001	ODE-223	2025-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208078-001	NPP	2025-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208078-001	ODE-223	2025-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208078-001	NPP	2025-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208078-001	ODE-223	2025-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208078-001	NPP	2025-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208078-001	ODE-223	2025-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208078-001	NPP	2025-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208078-001	ODE-223	2025-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208078-001	NPP	2025-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208078-001	ODE-223	2025-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208078-001	NPP	2025-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208078-001	ODE-223	2025-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208078-001	NPP	2025-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208078-001	ODE-223	2025-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208078-001	NPP	2025-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208078-001	ODE-223	2025-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208078-001	NPP	2025-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208078-001	ODE-223	2025-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208078-001	NPP	2025-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208078-001	ODE-223	2025-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208078-001	NPP	2025-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208078-001	ODE-223	2025-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208078-001	NPP	2025-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208078-001	ODE-223	2025-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208078-001	NCE	2023-11-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208078-001	ODE-223	2025-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208078-001	NCE	2023-11-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208078-001	ODE-223	2025-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208078-001	NCE	2023-11-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208078-001	ODE-223	2025-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208078-001	NCE	2023-11-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208078-001	ODE-223	2025-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208078-001	NCE	2023-11-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208078-001	ODE-223	2025-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208078-001	NCE	2023-11-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208078-001	ODE-223	2025-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208078-001	NCE	2023-11-28	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Firdapse
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMIFAMPRIDINE PHOSPHATE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8HF8FIN815	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2106343	Internal RxNorm lookup
2107518	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
f015fe60-3128-4a43-8c31-19fc6b5def3f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
be5e1632-ea67-4526-852b-e88fa4d9ee01	Product name	1	20190802
ac48b7ac-cf50-4bcf-ac41-29203ef41712	Product name	1	20190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69616-211-03	2020-07-22	C162847	48780-1	ab0e2407-33f4-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018
69616-211-06	2020-07-22	C162847	48780-1	ab0e2407-33f4-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018
69616-211-08	2020-07-22	C162847	48780-1	ab0e2407-33f4-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use FIRDAPSE ® safely and effectively. See full prescribing information for FIRDAPSE ® . FIRDAPSE ® (amifampridine) tablets, for oral use Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69616-211-03	Firdapse	240 in 1 BOTTLE, PLASTIC	TABLET	240	15
69616-211-04	Firdapse	10 in 1 BLISTER PACK	TABLET	10	15
69616-211-06	Firdapse	12 in 1 CARTON	TABLET	12	15
69616-211-08	Firdapse	60 in 1 BOTTLE, PLASTIC	TABLET	60	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69616-211-03	EA - Each	69616-211	20ad9e88-3723-411e-bd3b-1daa030a7a96	1	2019-04-11
69616-211-04	EA - Each	69616-211	5e9ad9a7-ece4-4e1c-8f53-24a48e2a5fdb	1	2019-01-24
69616-211-06	EA - Each	69616-211	17263468-4c6a-408e-8d77-25e99c3ec667	1	2019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69616-211	FIRDAPSE (AMIFAMPRIDINE PHOSPHATE) TABLET [CATALYST PHARMACEUTICALS, INC. ]	14	Current NDC, Legacy NDC, 4 package rows	20240627_f015fe60-3128-4a43-8c31-19fc6b5def3f.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
Firdapse	AMIFAMPRIDINE PHOSPHATE	Catalyst Pharmaceuticals, Inc.	f015fe60-3128-4a43-8c31-19fc6b5def3f	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208078 application number: NDA208078 ndc (product): 69616-211

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8HF8FIN815	AMIFAMPRIDINE PHOSPHATE	446254-47-3	AMIFAMPRIDINE PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2106343	amifampridine 10 MG Oral Tablet	PSN	f015fe60-3128-4a43-8c31-19fc6b5def3f	15
2107518	Firdapse 10 MG Oral Tablet	PSN	f015fe60-3128-4a43-8c31-19fc6b5def3f	15
2107518	amifampridine 10 MG Oral Tablet [Firdapse]	SBD	f015fe60-3128-4a43-8c31-19fc6b5def3f	15
2106343	amifampridine 10 MG Oral Tablet	SCD	f015fe60-3128-4a43-8c31-19fc6b5def3f	15
2106343	amifampridine 10 MG (as amifampridine phosphate 18.98 MG) Oral Tablet	SY	f015fe60-3128-4a43-8c31-19fc6b5def3f	15
2107518	Firdapse 10 MG (as amifampridine phosphate 18.98 MG) Oral Tablet	SY	f015fe60-3128-4a43-8c31-19fc6b5def3f	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69616-211-03	69616021103	240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03)	240 tablet	2019-01-07	0000-00-00	No	No	Current
69616-211-04	69616021104	10 in 1 BLISTER PACK						Historical
69616-211-06	69616021106	12 BLISTER PACK in 1 CARTON (69616-211-06) / 10 TABLET in 1 BLISTER PACK (69616-211-04)	12 blister pack	2019-01-07	0000-00-00	No	No	Current
69616-211-08	69616021108	60 TABLET in 1 BOTTLE, PLASTIC (69616-211-08)	60 tablet	2019-01-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Firdapse	Catalyst Pharmaceuticals, Inc. \| Catalent Micron Technologies, Inc. \| Pharmaceutics International, Inc. \| PCI Pharma Services Canada, Inc. \| Quality Chemical Laboratories, LLC \| Robertson-Microlit Laboratories Inc. \| SGS Canada Inc. \| SGS North America Inc.	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	15