FDA.reportPublic FDA data

Phenobarbital

Product NDC
0603-5168
11-digit product format
006035168
Labeler code
0603
Product ID
0603-5168_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
2001-12-01
Marketing end
2027-02-28
Substance
PHENOBARBITAL
Active strength
97.2 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
PHENOBARBITAL97.2 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
0603-5168-21Phenobarbital100 in 1 BOTTLE, PLASTICTABLET10013
0603-5168-32Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-5168-21EA - Each0603-51681d85160d-a55e-4603-8ddb-9f6f540fadaa12012-07-24
0603-5168-32EA - Each0603-5168e38bf29d-f21d-4873-84d2-31ea970ed12e12012-07-24

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
0603-5168PHENOBARBITAL 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
199164PHENobarbital 97.2 MG Oral TabletPSN1750cd18-13e5-4ee5-8b45-4e56ea4d5ba6101
199164phenobarbital 97.2 MG Oral TabletSCD1750cd18-13e5-4ee5-8b45-4e56ea4d5ba6101
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
0603-5168-2100603516821100 TABLET in 1 BOTTLE, PLASTIC (0603-5168-21) 100 tablet2001-12-012027-02-28NoNoCurrent
0603-5168-32006035168321000 TABLET in 1 BOTTLE, PLASTIC (0603-5168-32) 1000 tablet2001-12-012026-05-31NoNoCurrent