Home NDC 49938-110 Ruzurgi
Product NDC 49938-110
11-digit product format 499380110
Labeler code 49938
Product ID 49938-110_1ed617b0-47e8-4a7c-b9b0-e92e08d4c4a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amifampridine
Dosage form TABLET
Route ORAL
Labeler Jacobus Pharmaceutical Company,Inc
Application NDA209321
Marketing category NDA
Marketing start 2019-07-02
Marketing end 0000-00-00
Substance AMIFAMPRIDINE
Active strength 10 mg/1
Pharmacologic classes Potassium Channel Blocker [EPC],Potassium Channel Antagonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog .
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.
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 2019-12-13 00:20 UTC 2019-12 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209321-001 RUZURGI 10MG TABLET / ORAL RLD, RS 2019-05-06 ea99ee380514…
Observed Orange Book exclusivity history# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49938-110-01 49938011001 1 BOTTLE, PLASTIC in 1 CARTON (49938-110-01) > 100 TABLET in 1 BOTTLE, PLASTIC 2019-07-02 0000-00-00 No No Current