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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
860d9c27-9c73-4d2c-bc31-a37472a38f7cAvailable 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
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

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 SODIUMBryant Ranch Prepack860d9c27-9c73-4d2c-bc31-a37472a38f7c2025-08-18Warnings, Adverse reactionsExact identifier
ndc (product): 63629-1997

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