FDA.reportPublic FDA data

PHENOBARBITAL

Product NDC
70752-165
11-digit product format
707520165
Labeler code
70752
Product ID
70752-165_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
15 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
PHENOBARBITAL15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YQE403BP4DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198083Internal RxNorm lookup
198089Internal RxNorm lookup
312357Internal RxNorm lookup
312362Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81930c69-d073-402a-9089-ae891bfddc25Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70752-165-102023-02-16PHENOBARBITAL TABLETS, USP C-IV Rx only
70752-165-112023-02-16PHENOBARBITAL TABLETS, USP C-IV Rx only
70752-165-142023-02-16PHENOBARBITAL TABLETS, USP C-IV Rx only
70752-165-102023-01-30PHENOBARBITAL TABLETS, USP C-IV Rx only
70752-165-112023-01-30PHENOBARBITAL TABLETS, USP C-IV Rx only
70752-165-142023-01-30PHENOBARBITAL TABLETS, USP C-IV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-165-10PHENOBARBITAL100 in 1 BOTTLETABLET1003
70752-165-11PHENOBARBITAL1000 in 1 BOTTLETABLET10003
70752-165-14PHENOBARBITAL500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-165PHENOBARBITAL TABLET [QUAGEN PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 3 package rows20230217_81930c69-d073-402a-9089-ae891bfddc25.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHENOBARBITALPHENOBARBITALQUAGEN PHARMACEUTICALS LLC81930c69-d073-402a-9089-ae891bfddc252023-02-16Warnings, Adverse reactionsExact identifier
ndc (product): 70752-165

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
70752-165-1070752016510100 TABLET in 1 BOTTLE (70752-165-10) 100 tablet2020-09-300000-00-00NoNoCurrent
70752-165-11707520165111000 TABLET in 1 BOTTLE (70752-165-11) 1000 tablet2020-09-300000-00-00NoNoCurrent
70752-165-1470752016514500 TABLET in 1 BOTTLE (70752-165-14) 500 tablet2020-09-300000-00-00NoNoCurrent