Sodium Phenylacetate and Sodium Benzoate

Product NDC
72266-247
11-digit product format
722660247
Labeler code
72266
Product ID
72266-247_ea2bf61c-4a58-33ba-e053-2995a90aa2e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Phenylacetate and Sodium Benzoate
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
FOSUN PHARMA USA INC
Application
ANDA208521
Marketing category
ANDA
Marketing start
2022-08-18
Marketing end
0000-00-00
Substance
SODIUM BENZOATE; SODIUM PHENYLACETATE
Active strength
100 mg/mL; mg/mL
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Nitrogen Binding Agent [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72266-247-01722660247011 VIAL, SINGLE-DOSE in 1 CARTON (72266-247-01) > 50 mL in 1 VIAL, SINGLE-DOSE2022-08-180000-00-00NoNoCurrent