FDA.reportPublic FDA data

Phenobarbital Oral Solution

Product NDC
0121-1884
11-digit product format
001211884
Labeler code
0121
Product ID
0121-1884_8ca47fca-d85e-4029-a4d3-bc341be13890
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-08-20
Substance
PHENOBARBITAL
Active strength
30 mg/7.5mL
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 Oral Solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL30 mg/7.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui702519

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1884-07Phenobarbital Oral Solution7.5 mL in 1 CUP, UNIT-DOSESOLUTION7.55
0121-1884-50Phenobarbital Oral Solution10 in 1 TRAYSOLUTION105
0121-1884-50Phenobarbital Oral Solution5 in 1 CASESOLUTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1884-07ML - Milliliter0121-1884155ae003-5a14-4cbd-b510-3dfdaffbe2fc12021-12-08
0121-1884-50ML - Milliliter0121-18847fd64d56-59b1-4cff-9356-7969403f1af512021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1884PHENOBARBITAL ORAL SOLUTION (PHENOBARBITAL ORAL) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]5Current NDC, Legacy NDC, 3 package rows20241121_30c20889-2b12-4d73-b4ce-0e1b49b3e3c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN30c20889-2b12-4d73-b4ce-0e1b49b3e3c35
702519phenobarbital 4 MG/ML Oral SolutionSCD30c20889-2b12-4d73-b4ce-0e1b49b3e3c35
702519phenobarbital 20 MG per 5 ML Oral SolutionSY30c20889-2b12-4d73-b4ce-0e1b49b3e3c35
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY30c20889-2b12-4d73-b4ce-0e1b49b3e3c35
702519phenobarbital 60 MG per 15 ML Oral SolutionSY30c20889-2b12-4d73-b4ce-0e1b49b3e3c35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1884-07001211884077.5 mL in 1 CUP, UNIT-DOSE7.5 mlHistorical
0121-1884-50001211884505 TRAY in 1 CASE (0121-1884-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 7.5 mL in 1 CUP, UNIT-DOSE (0121-1884-07) 5 tray2021-08-200000-00-00NoNoCurrent