FDA.reportPublic FDA data

PHENOBARBITAL

Product NDC
70752-162
11-digit product format
707520162
Labeler code
70752
Product ID
70752-162_234e0cf8-e1c9-47a2-8fa3-8a4db929c866
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOBARBITAL
Dosage form
TABLET
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-09-15
Substance
PHENOBARBITAL
Active strength
32.4 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
PHENOBARBITAL32.4 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70752-162-102023-02-16C16284748780-1f386c649-b2a1-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only
70752-162-112023-02-16C16284748780-1f386c649-b2a1-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only
70752-162-142023-02-16C16284748780-1f386c649-b2a1-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only
70752-162-102023-01-30C16284748780-1f386c649-b2a1-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only
70752-162-112023-01-30C16284748780-1f386c649-b2a1-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only
70752-162-142023-01-30C16284748780-1f386c649-b2a1-0266-e053-dadaa90a7c1aPHENOBARBITAL TABLETS, USP C-IV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-162-10PHENOBARBITAL100 in 1 BOTTLETABLET1002
70752-162-11PHENOBARBITAL1000 in 1 BOTTLETABLET10002
70752-162-14PHENOBARBITAL500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-162PHENOBARBITAL TABLET [QUAGEN PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 3 package rows20230217_7e6853a4-478d-40e3-b041-4cff02a74c8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198086PHENobarbital 16.2 MG Oral TabletPSN7e6853a4-478d-40e3-b041-4cff02a74c8c2
199167PHENobarbital 32.4 MG Oral TabletPSN7e6853a4-478d-40e3-b041-4cff02a74c8c2
199168PHENobarbital 64.8 MG Oral TabletPSN7e6853a4-478d-40e3-b041-4cff02a74c8c2
199164PHENobarbital 97.2 MG Oral TabletPSN7e6853a4-478d-40e3-b041-4cff02a74c8c2
198086phenobarbital 16.2 MG Oral TabletSCD7e6853a4-478d-40e3-b041-4cff02a74c8c2
199167phenobarbital 32.4 MG Oral TabletSCD7e6853a4-478d-40e3-b041-4cff02a74c8c2
199168phenobarbital 64.8 MG Oral TabletSCD7e6853a4-478d-40e3-b041-4cff02a74c8c2
199164phenobarbital 97.2 MG Oral TabletSCD7e6853a4-478d-40e3-b041-4cff02a74c8c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-162-1070752016210100 TABLET in 1 BOTTLE (70752-162-10) 100 tablet2020-09-150000-00-00NoNoCurrent
70752-162-11707520162111000 TABLET in 1 BOTTLE (70752-162-11) 1000 tablet2020-09-150000-00-00NoNoCurrent
70752-162-1470752016214500 TABLET in 1 BOTTLE (70752-162-14) 500 tablet2020-09-150000-00-00NoNoCurrent