Home NDC 69367-691-05 Phenobarbital
Product NDC 69367-691
Requested package NDC 69367-691-05
11-digit product format 693670691
Labeler code 69367
Product ID 69367-691_b8256561-2c8d-4b02-8a59-5fbc524e4eb3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Phenobarbital
Dosage form TABLET
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2023-09-08
Substance PHENOBARBITAL
Active strength 15 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENOBARBITAL 15 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198083 Internal RxNorm lookup 198089 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69367-691-01 Phenobarbital 100 in 1 BOTTLE TABLET 100 1 69367-691-05 Phenobarbital 500 in 1 BOTTLE TABLET 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-691 PHENOBARBITAL TABLET [WESTMINSTER PHARMACEUTICALS, LLC] 1 Current NDC, 2 package rows 20230915_4e70d33b-82f3-4a8e-a35b-ee658b3e0ab1.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69367-691-05 69367069105 500 TABLET in 1 BOTTLE (69367-691-05) 500 tablet 2023-09-08 No No Current