Home NDC 0603-5166 Phenobarbital
Product NDC 0603-5166
11-digit product format 006035166
Labeler code 0603
Product ID 0603-5166_f8c5136e-e35c-4425-8d49-b7f92c827b42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name phenobarbital
Dosage form TABLET
Route ORAL
Labeler Par Health USA, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2003-02-01
Marketing end 2027-02-28
Substance PHENOBARBITAL
Active strength 32.4 mg/1
DEA schedule CIV
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Additional Listing Data#
Finished product Yes
Brand name base Phenobarbital 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198086 Internal RxNorm lookup 199164 Internal RxNorm lookup 199167 Internal RxNorm lookup 199168 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 0603-5166-02 Phenobarbital 90 in 1 BOTTLE, PLASTIC TABLET 90 13 0603-5166-16 Phenobarbital 30 in 1 BOTTLE, PLASTIC TABLET 30 13 0603-5166-20 Phenobarbital 60 in 1 BOTTLE, PLASTIC TABLET 60 13 0603-5166-21 Phenobarbital 100 in 1 BOTTLE, PLASTIC TABLET 100 13 0603-5166-22 Phenobarbital 120 in 1 BOTTLE, PLASTIC TABLET 120 13 0603-5166-32 Phenobarbital 1000 in 1 BOTTLE, PLASTIC TABLET 1000 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENOBARBITAL ACTIVE INGREDIENT YQE403BP4D PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS] 6 PHENOBARBITAL ACTIVE MOIETY YQE403BP4D PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS] 6 PHENOBARBITAL ACTIVE INGREDIENT YQE403BP4D PHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 2 PHENOBARBITAL ACTIVE MOIETY YQE403BP4D PHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PHENOBARBITAL TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION] 2 PHENOBARBITAL ACTIVE INGREDIENT YQE403BP4D PHENOBARBITAL TABLET [CONTRACT PHARMACY SERVICES-PA] 1 PHENOBARBITAL ACTIVE INGREDIENT YQE403BP4D PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 PHENOBARBITAL ACTIVE MOIETY YQE403BP4D PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 PHENOBARBITAL ACTIVE MOIETY YQE403BP4D PHENOBARBITAL TABLET [CONTRACT PHARMACY SERVICES-PA] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PHENOBARBITAL TABLET [CONTRACT PHARMACY SERVICES-PA] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PHENOBARBITAL TABLET [CONTRACT PHARMACY SERVICES-PA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PHENOBARBITAL TABLET [CONTRACT PHARMACY SERVICES-PA] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENOBARBITAL TABLET [CONTRACT PHARMACY SERVICES-PA] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PHENOBARBITAL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PHENOBARBITAL TABLET [CONTRACT PHARMACY SERVICES-PA] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0603-5166 PHENOBARBITAL TABLET [ENDO USA, INC.] 12 Current NDC, Legacy NDC, 6 package rows 20240913_069b92ce-0061-4724-8c25-08d8596770a2.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 Marketing end Sample Exclude flag Status 0603-5166-02 00603516602 90 in 1 BOTTLE, PLASTIC Historical 0603-5166-16 00603516616 30 in 1 BOTTLE, PLASTIC Historical 0603-5166-20 00603516620 60 in 1 BOTTLE, PLASTIC Historical 0603-5166-21 00603516621 100 TABLET in 1 BOTTLE, PLASTIC (0603-5166-21) 100 tablet 2003-02-01 2027-02-28 No No Current 0603-5166-22 00603516622 120 in 1 BOTTLE, PLASTIC Historical 0603-5166-32 00603516632 1000 TABLET in 1 BOTTLE, PLASTIC (0603-5166-32) 1000 tablet 2003-02-01 2026-05-31 No No Current