AMPYRA

Product NDC
10144-427
11-digit product format
101440427
Labeler code
10144
Product ID
10144-427_dda9045d-2f23-412c-9543-74832f421739
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dalfampridine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Merz Pharmaceuticals, LLC
Application
NDA022250
Marketing category
NDA
Marketing start
2010-03-01
Substance
DALFAMPRIDINE
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022250-001AMPYRADALFAMPRIDINE10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022250-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-2287673890dc5c…
2021-03-12 10:30 UTC2021-03N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-223f01610625f2…
2019-09-15 20:21 UTC2019-09N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22b00525d2431f…
2019-07-19 19:46 UTC2019-07N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-223f0d92c62455…
2023-05-13 08:27 UTC2023-05N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22053a50430f4f…
2023-01-26 05:58 UTC2023-01N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022250-001AMPYRA10MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2010-01-22e64feba35796…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N022250-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022250-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022250-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022250-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022250-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022250-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022250-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022250-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022250-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022250-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022250-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022250-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022250-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022250-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022250-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022250-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022250-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022250-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022250-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022250-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022250-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022250-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N022250-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022250-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022250-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022250-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N022250-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N022250-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022250-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022250-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022250-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022250-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022250-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022250-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022250-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N022250-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N022250-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022250-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022250-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022250-001AB1e64feba35796…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N022250-00184407032025-04-08U-1030Delist requested2013-06-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022250-00183544372026-12-22U-1030Delist requested2013-02-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022250-00180078262027-05-26U-1030Delist requested2011-09-2874a2ff9319b5…
2019-12-14 00:12 UTC2019-12N022250-00184407032025-04-08U-1030Delist requested2013-06-123f01610625f2…
2019-12-14 00:12 UTC2019-12N022250-00183544372026-12-22U-1030Delist requested2013-02-133f01610625f2…
2019-12-14 00:12 UTC2019-12N022250-00180078262027-05-26U-1030Delist requested2011-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09N022250-00199189732024-12-13U-10302018-04-17b00525d2431f…
2019-09-15 20:21 UTC2019-09N022250-00186636852025-01-18U-10302014-04-02b00525d2431f…
2019-09-15 20:21 UTC2019-09N022250-00184407032025-04-08U-10302013-06-12b00525d2431f…
2019-09-15 20:21 UTC2019-09N022250-00183544372026-12-22U-10302013-02-13b00525d2431f…
2019-09-15 20:21 UTC2019-09N022250-00180078262027-05-26U-10302011-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N022250-00199189732024-12-13U-10302018-04-17ea99ee380514…
2019-07-19 19:46 UTC2019-07N022250-00186636852025-01-18U-10302014-04-02ea99ee380514…
2019-07-19 19:46 UTC2019-07N022250-00184407032025-04-08U-10302013-06-12ea99ee380514…
2019-07-19 19:46 UTC2019-07N022250-00183544372026-12-22U-10302013-02-13ea99ee380514…
2019-07-19 19:46 UTC2019-07N022250-00180078262027-05-26U-10302011-09-28ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DALFAMPRIDINE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BH3B64OKL9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
897021Internal RxNorm lookup
897025Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9109832c-cb3c-b72f-db80-0e6688f08431Product name520190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10144-427-60AMPYRA60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10144-427-60EA - Each10144-427efcd7340-55b3-4f6f-a82f-d4690ba04aa512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10144-427AMPYRA (DALFAMPRIDINE) TABLET, FILM COATED, EXTENDED RELEASE [MERZ PHARMACEUTICALS, LLC]21Current NDC, Legacy NDC, 1 package rows20241222_550eb76a-e4a6-4fa1-ad65-c0fd8b0ce783.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMPYRADALFAMPRIDINEMerz Pharmaceuticals, LLC550eb76a-e4a6-4fa1-ad65-c0fd8b0ce7832026-01-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 022250
application number: NDA022250
ndc (product): 10144-427
AMPYRADALFAMPRIDINEMerz Pharmaceuticals, LLC974fb2af-7012-4989-b330-e44a31c9c3e52025-05-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 022250
application number: NDA022250

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
897025Ampyra 10 MG 12HR Extended Release Oral TabletPSN550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
897021dalfampridine 10 MG 12HR Extended Release Oral TabletPSN550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
89702512 HR dalfampridine 10 MG Extended Release Oral Tablet [Ampyra]SBD550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
89702112 HR dalfampridine 10 MG Extended Release Oral TabletSCD550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
89702512 HR Ampyra 10 MG Extended Release Oral TabletSY550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
897025Ampyra 10 MG 12 HR Extended Release Oral TabletSY550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322
897021dalfampridine 10 MG 12 HR Extended Release Oral TabletSY550eb76a-e4a6-4fa1-ad65-c0fd8b0ce78322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10144-427-601014404276060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60) 2010-03-010000-00-00NoNoCurrent