FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
63629-1997
11-digit product format
636291997
Labeler code
63629
Product ID
63629-1997_161b97e9-9e06-4c7b-af5c-67e993d6e3d4
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
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 Identifiers#

Field, Values table
FieldValues
UniiSW9M9BB5K3
Rxcui312370

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
63629-1997-1Phenobarbital Sodium25 in 1 BOX, UNIT-DOSEINJECTION25105
63629-1997-2Phenobarbital Sodium1 mL in 1 VIALINJECTION1105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1997-1ML - Milliliter63629-199773dc55c0-5d8f-43fd-a2ad-7d13941c914a12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1997PHENOBARBITAL SODIUM INJECTION [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240910_860d9c27-9c73-4d2c-bc31-a37472a38f7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312370PHENobarbital 130 MG/ML Injectable SolutionPSN860d9c27-9c73-4d2c-bc31-a37472a38f7c105
312370phenobarbital 130 MG/ML Injectable SolutionSCD860d9c27-9c73-4d2c-bc31-a37472a38f7c105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1997-16362919970125 VIAL in 1 BOX, UNIT-DOSE (63629-1997-1) / 1 mL in 1 VIAL (63629-1997-2) 25 vial2021-05-040000-00-00NoNoCurrent
63629-1997-2636291997021 mL in 1 VIAL1 mlHistorical