FDA.reportPublic FDA data

PHENOBARBITAL

Product NDC
70752-166
11-digit product format
707520166
Labeler code
70752
Product ID
70752-166_b9516314-0ea2-46f0-9354-20bd0bb54e4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOBARBITAL
Dosage form
TABLET
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-09-30
Substance
PHENOBARBITAL
Active strength
30 mg/1
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PHENOBARBITAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui198083, 198089, 312357, 312362

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70752-166-102023-02-16C16284748780-1f386c64a-36f0-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only
70752-166-112023-02-16C16284748780-1f386c64a-36f0-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only
70752-166-142023-02-16C16284748780-1f386c64a-36f0-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only
70752-166-102023-01-30C16284748780-1f386c64a-36f0-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only
70752-166-112023-01-30C16284748780-1f386c64a-36f0-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only
70752-166-142023-01-30C16284748780-1f386c64a-36f0-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-166-10PHENOBARBITAL100 in 1 BOTTLETABLET1003
70752-166-11PHENOBARBITAL1000 in 1 BOTTLETABLET10003
70752-166-14PHENOBARBITAL500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-166PHENOBARBITAL TABLET [QUAGEN PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 3 package rows20230217_81930c69-d073-402a-9089-ae891bfddc25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSN81930c69-d073-402a-9089-ae891bfddc253
312357PHENobarbital 15 MG Oral TabletPSN81930c69-d073-402a-9089-ae891bfddc253
312362PHENobarbital 30 MG Oral TabletPSN81930c69-d073-402a-9089-ae891bfddc253
198089PHENobarbital 60 MG Oral TabletPSN81930c69-d073-402a-9089-ae891bfddc253
198083phenobarbital 100 MG Oral TabletSCD81930c69-d073-402a-9089-ae891bfddc253
312357phenobarbital 15 MG Oral TabletSCD81930c69-d073-402a-9089-ae891bfddc253
312362phenobarbital 30 MG Oral TabletSCD81930c69-d073-402a-9089-ae891bfddc253
198089phenobarbital 60 MG Oral TabletSCD81930c69-d073-402a-9089-ae891bfddc253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-166-1070752016610100 TABLET in 1 BOTTLE (70752-166-10) 100 tablet2020-09-300000-00-00NoNoCurrent
70752-166-11707520166111000 TABLET in 1 BOTTLE (70752-166-11) 1000 tablet2020-09-300000-00-00NoNoCurrent
70752-166-1470752016614500 TABLET in 1 BOTTLE (70752-166-14) 500 tablet2020-09-300000-00-00NoNoCurrent