Home NDC 62135-519 Phenobarbital
Product NDC 62135-519
11-digit product format 621350519
Labeler code 62135
Product ID 62135-519_5a0a21bf-3080-2322-e063-6394a90a387d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenobarbital
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-08-17
Substance PHENOBARBITAL
Active strength 100 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 100 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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198083 Internal RxNorm lookup 198086 Internal RxNorm lookup 198089 Internal RxNorm lookup 199164 Internal RxNorm lookup 199167 Internal RxNorm lookup 199168 Internal RxNorm lookup 312357 Internal RxNorm lookup 312362 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 62135-519-90 62135051990 90 TABLET in 1 BOTTLE (62135-519-90) 90 tablet 2026-08-17 No No Current