FDA.reportPublic FDA data

Phenobarbital

Product NDC
0603-5165
11-digit product format
006035165
Labeler code
0603
Product ID
0603-5165_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
2002-03-01
Marketing end
2027-01-31
Substance
PHENOBARBITAL
Active strength
16.2 mg/1
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL16.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui198086, 199164, 199167, 199168

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-5165-21Phenobarbital100 in 1 BOTTLE, PLASTICTABLET10013
0603-5165-32Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-5165-21EA - Each0603-516523fee4d4-52d7-4206-854d-39ac9e8ca36312012-07-24
0603-5165-32EA - Each0603-51659eb724f5-a82e-4350-9cbc-aa11d17b769712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOBARBITALACTIVE INGREDIENTYQE403BP4DPHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
PHENOBARBITALACTIVE MOIETYYQE403BP4DPHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PHENOBARBITAL TABLET [QUALITEST PHARMACEUTICALS]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-5165PHENOBARBITAL TABLET [ENDO USA, INC.]12Current NDC, Legacy NDC, 2 package rows20240913_069b92ce-0061-4724-8c25-08d8596770a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198086PHENobarbital 16.2 MG Oral TabletPSNb53fc65c-02f2-4a77-914c-8f2c78fca546103
198086phenobarbital 16.2 MG Oral TabletSCDb53fc65c-02f2-4a77-914c-8f2c78fca546103
198086PHENobarbital 16.2 MG Oral TabletPSNf85515e4-06cf-42d7-8e3e-066874787a04101
198086phenobarbital 16.2 MG Oral TabletSCDf85515e4-06cf-42d7-8e3e-066874787a04101
198086PHENobarbital 16.2 MG Oral TabletPSN069b92ce-0061-4724-8c25-08d8596770a213
199167PHENobarbital 32.4 MG Oral TabletPSN069b92ce-0061-4724-8c25-08d8596770a213
199168PHENobarbital 64.8 MG Oral TabletPSN069b92ce-0061-4724-8c25-08d8596770a213
199164PHENobarbital 97.2 MG Oral TabletPSN069b92ce-0061-4724-8c25-08d8596770a213
198086phenobarbital 16.2 MG Oral TabletSCD069b92ce-0061-4724-8c25-08d8596770a213
199167phenobarbital 32.4 MG Oral TabletSCD069b92ce-0061-4724-8c25-08d8596770a213
199168phenobarbital 64.8 MG Oral TabletSCD069b92ce-0061-4724-8c25-08d8596770a213
199164phenobarbital 97.2 MG Oral TabletSCD069b92ce-0061-4724-8c25-08d8596770a213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-5165-2100603516521100 TABLET in 1 BOTTLE, PLASTIC (0603-5165-21) 100 tablet2002-03-012027-01-31NoNoCurrent
0603-5165-32006035165321000 TABLET in 1 BOTTLE, PLASTIC (0603-5165-32) 1000 tablet2002-03-012026-05-31NoNoCurrent