Home NDC 0378-0509-91 dalfampridine
Product NDC 0378-0509
Requested package NDC 0378-0509-91
11-digit product format 003780509
Labeler code 0378
Product ID 0378-0509_c1c3e18e-4723-4760-a746-9cbea2b1c812
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dalfampridine
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA022250
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-09-10
Marketing end 2022-05-31
Substance DALFAMPRIDINE
Active strength 10 mg/1
Pharmacologic classes Potassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N022250-001 AMPYRA DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022250-001 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 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022250-001 AMPYRA 10MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2010-01-22 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022250-001 8440703 2025-04-08 U-1030 Delist requested 2013-06-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022250-001 8354437 2026-12-22 U-1030 Delist requested 2013-02-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022250-001 8007826 2027-05-26 U-1030 Delist requested 2011-09-28 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022250-001 8440703 2025-04-08 U-1030 Delist requested 2013-06-12 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022250-001 8354437 2026-12-22 U-1030 Delist requested 2013-02-13 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022250-001 8007826 2027-05-26 U-1030 Delist requested 2011-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022250-001 9918973 2024-12-13 U-1030 2018-04-17 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022250-001 8663685 2025-01-18 U-1030 2014-04-02 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022250-001 8440703 2025-04-08 U-1030 2013-06-12 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022250-001 8354437 2026-12-22 U-1030 2013-02-13 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022250-001 8007826 2027-05-26 U-1030 2011-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022250-001 9918973 2024-12-13 U-1030 2018-04-17 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022250-001 8663685 2025-01-18 U-1030 2014-04-02 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022250-001 8440703 2025-04-08 U-1030 2013-06-12 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022250-001 8354437 2026-12-22 U-1030 2013-02-13 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022250-001 8007826 2027-05-26 U-1030 2011-09-28 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-0509-91 00378050991 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0509-91) 2018-09-10 2022-05-31 No No Current