FDA.reportPublic FDA data

Phenobarbital

Product NDC
0121-0531
Requested package NDC
0121-0531-15
11-digit product format
001210531
Labeler code
0121
Product ID
0121-0531_d4dbd9ed-e7bc-038e-e053-2a95a90a8a27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2007-02-19
Substance
PHENOBARBITAL
Active strength
20 mg/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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL20 mg/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
037c7532-7688-44fd-8c76-d25e8adf5fb5Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0531-05Phenobarbital10 in 1 TRAYSOLUTION103
0121-0531-05Phenobarbital10 in 1 CASESOLUTION103
0121-0531-07Phenobarbital10 in 1 CASESOLUTION103
0121-0531-07Phenobarbital10 in 1 TRAYSOLUTION103
0121-0531-15Phenobarbital10 in 1 TRAYSOLUTION103
0121-0531-15Phenobarbital10 in 1 CASESOLUTION103
0121-0531-16Phenobarbital12 in 1 CASESOLUTION123
0121-0531-16Phenobarbital473 mL in 1 BOTTLESOLUTION4733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0531PHENOBARBITAL SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3Current NDC, Legacy NDC, 8 package rows20220106_037c7532-7688-44fd-8c76-d25e8adf5fb5.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
PhenobarbitalPHENOBARBITALPharmaceutical Associates, Inc.037c7532-7688-44fd-8c76-d25e8adf5fb52022-01-05Warnings, Adverse reactionsExact identifier
ndc (package): 0121-0531-15
ndc (product): 0121-0531
ndc11 (package): 00121053115

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN037c7532-7688-44fd-8c76-d25e8adf5fb53
702519phenobarbital 4 MG/ML Oral SolutionSCD037c7532-7688-44fd-8c76-d25e8adf5fb53
702519phenobarbital 20 MG per 5 ML Oral SolutionSY037c7532-7688-44fd-8c76-d25e8adf5fb53
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY037c7532-7688-44fd-8c76-d25e8adf5fb53
702519phenobarbital 60 MG per 15 ML Oral SolutionSY037c7532-7688-44fd-8c76-d25e8adf5fb53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0531-150012105311510 TRAY in 1 CASE (0121-0531-15) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE10 tray2007-02-190000-00-00NoNoCurrent