FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
54288-136
11-digit product format
542880136
Labeler code
54288
Product ID
54288-136_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
65 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 SODIUM65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSW9M9BB5K3
Rxcui198368, 312370

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
54288-136-01Phenobarbital Sodium1 mL in 1 VIALINJECTION18
54288-136-10Phenobarbital Sodium10 in 1 CARTONINJECTION108
54288-136-25Phenobarbital Sodium25 in 1 CARTONINJECTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-136-01ML - Milliliter54288-136c35641c2-3c45-45db-9610-7c51e4bfee1a12022-05-04
54288-136-10ML - Milliliter54288-136c7037228-264f-49ff-97f0-f2ebed386e5912022-05-04
54288-136-25ML - Milliliter54288-136835e5d0a-dae6-4df0-8e6c-827e58c5377512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-136PHENOBARBITAL SODIUM INJECTION [BPI LABS LLC]7Current NDC, Legacy NDC, 3 package rows20250213_b42d35de-a07a-4db5-998d-d4dbb92342cf.zip

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
54288-136-01542880136011 mL in 1 VIAL1 mlHistorical
54288-136-105428801361010 VIAL in 1 CARTON (54288-136-10) / 1 mL in 1 VIAL (54288-136-01) 10 vial2022-01-070000-00-00NoNoCurrent
54288-136-255428801362525 VIAL in 1 CARTON (54288-136-25) / 1 mL in 1 VIAL (54288-136-01) 25 vial2023-03-17NoNoHistorical