FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
54288-137
11-digit product format
542880137
Labeler code
54288
Product ID
54288-137_1d53fada-d36d-4a1a-bb13-fff7d1a177a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
BPI Labs LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-01-07
Substance
PHENOBARBITAL SODIUM
Active strength
130 mg/mL
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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL SODIUM130 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SW9M9BB5K3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198368Internal RxNorm lookup
312370Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b42d35de-a07a-4db5-998d-d4dbb92342cfAvailable 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
54288-137-01Phenobarbital Sodium1 mL in 1 VIALINJECTION18
54288-137-10Phenobarbital Sodium10 in 1 CARTONINJECTION108
54288-137-25Phenobarbital Sodium25 in 1 CARTONINJECTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-137-01ML - Milliliter54288-1376c654ba0-776f-4aed-9018-ab9bfac352f612022-05-04
54288-137-10ML - Milliliter54288-137bffe3905-18c1-4c68-abdf-7cf0e9391d9e12022-05-04
54288-137-25ML - Milliliter54288-1373e96cce5-e717-4d25-ace6-35df05af9e7912023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-137PHENOBARBITAL SODIUM INJECTION [BPI LABS LLC]7Current NDC, Legacy NDC, 3 package rows20250213_b42d35de-a07a-4db5-998d-d4dbb92342cf.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 SodiumPHENOBARBITAL SODIUMBPI Labs LLCb42d35de-a07a-4db5-998d-d4dbb92342cf2025-12-17Warnings, Adverse reactionsExact identifier
ndc (product): 54288-137

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312370PHENobarbital 130 MG/ML Injectable SolutionPSNb42d35de-a07a-4db5-998d-d4dbb92342cf8
198368PHENobarbital 65 MG/ML Injectable SolutionPSNb42d35de-a07a-4db5-998d-d4dbb92342cf8
312370phenobarbital 130 MG/ML Injectable SolutionSCDb42d35de-a07a-4db5-998d-d4dbb92342cf8
198368phenobarbital 65 MG/ML Injectable SolutionSCDb42d35de-a07a-4db5-998d-d4dbb92342cf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54288-137-01542880137011 mL in 1 VIAL1 mlHistorical
54288-137-105428801371010 VIAL in 1 CARTON (54288-137-10) / 1 mL in 1 VIAL (54288-137-01) 10 vial2022-01-080000-00-00NoNoCurrent
54288-137-255428801372525 VIAL in 1 CARTON (54288-137-25) / 1 mL in 1 VIAL (54288-137-01) 25 vial2023-03-17NoNoCurrent