Home NDC 70518-4718-0 Phenobarbital
Product NDC 70518-4718
Requested package NDC 70518-4718-0
11-digit product format 705184718
Labeler code 70518
Product ID 70518-4718_584bdbc5-42e5-3917-e063-6394a90af735
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenobarbital
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-08-03
Substance PHENOBARBITAL
Active strength 32.4 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Phenobarbital
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENOBARBITAL 32.4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YQE403BP4D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199167 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4718-0 70518471800 100 POUCH in 1 BOX (70518-4718-0) / 1 TABLET in 1 POUCH (70518-4718-1) 100 pouch 2026-08-03 No No Current