Nulibry

Product NDC
73129-001
11-digit product format
731290001
Labeler code
73129
Product ID
73129-001_763981b6-9ee5-4e66-9e99-b7022fb0eaaf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosdenopterin hydrobromide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Origin Biosciences, Inc.
Application
NDA214018
Marketing category
NDA
Marketing start
2021-03-30
Marketing end
0000-00-00
Substance
FOSDENOPTERIN HYDROBROMIDE
Active strength
10 mg/1
Pharmacologic classes
Cyclic Pyranopterin Monophosphate [EPC], Cyclic Pyranopterin Monophosphate [EXT]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73129-001-01EA - Each73129-001c5905a13-1574-465b-9c85-8bf9f75deccb12021-04-08
73129-001-99EA - Each73129-0014f876d16-ef9a-401f-b9e6-a3e7a4d830b312022-05-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73129-001-01731290001011 VIAL, SINGLE-DOSE in 1 CARTON (73129-001-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2021-03-300000-00-00NoNoCurrent
73129-001-99731290001991 VIAL, SINGLE-DOSE in 1 CARTON (73129-001-99) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE2021-03-300000-00-00YesNoCurrent