PHEBURANE

Product NDC
71770-100
11-digit product format
717700100
Labeler code
71770
Product ID
71770-100_5c309e18-6001-4bd1-93ae-17be10c3dad4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium phenylbutyrate
Dosage form
PELLET
Route
ORAL
Labeler
Medunik USA
Application
NDA216513
Marketing category
NDA
Marketing start
2022-08-26
Marketing end
0000-00-00
Substance
SODIUM PHENYLBUTYRATE
Active strength
483 mg/g
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]
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
71770-100-60EA - Each71770-1002430aea5-5438-490e-bfa9-9baaeec9763912018-07-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71770-100-1071770010010174 g in 1 BOTTLE (71770-100-10) 174 g2022-08-260000-00-00NoNoCurrent