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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702519Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30c20889-2b12-4d73-b4ce-0e1b49b3e3c3Available on FDA.report

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

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
Phenobarbital Oral SolutionPHENOBARBITAL ORALPAI Holdings, LLC dba PAI Pharma30c20889-2b12-4d73-b4ce-0e1b49b3e3c32024-11-19Warnings, Adverse reactionsExact identifier
ndc (product): 0121-1884

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