FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
72162-1329
11-digit product format
721621329
Labeler code
72162
Product ID
72162-1329_52f85abd-fbdc-440d-9d9b-4b58e3750da2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-02-05
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

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
72162-1329-2Phenobarbital Sodium25 in 1 BOX, UNIT-DOSEINJECTION25105
72162-1329-2Phenobarbital Sodium1 mL in 1 VIALINJECTION1105
72162-1329-4Phenobarbital Sodium1 mL in 1 VIALINJECTION1105
72162-1329-4Phenobarbital Sodium3 in 1 BOX, UNIT-DOSEINJECTION3105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1329-2ML - Milliliter72162-13290d7b899f-beb2-453a-a51d-dfe6621d574012023-05-05
72162-1329-4ML - Milliliter72162-1329624ba5b2-2d99-4e49-9693-6d6c3b8a59ce12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1329PHENOBARBITAL SODIUM INJECTION [BRYANT RANCH PREPACK]105Current NDC, 4 package rows20240919_7741e9ab-54ea-4c7e-9d64-daff922704ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198368PHENobarbital 65 MG/ML Injectable SolutionPSN7741e9ab-54ea-4c7e-9d64-daff922704ba105
198368phenobarbital 65 MG/ML Injectable SolutionSCD7741e9ab-54ea-4c7e-9d64-daff922704ba105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1329-27216213290225 VIAL in 1 BOX, UNIT-DOSE (72162-1329-2) / 1 mL in 1 VIAL25 vial2024-09-06NoNoCurrent
72162-1329-4721621329043 VIAL in 1 BOX, UNIT-DOSE (72162-1329-4) / 1 mL in 1 VIAL3 vial2024-09-06NoNoCurrent