FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
63629-1998
Requested package NDC
63629-1998-1
11-digit product format
636291998
Labeler code
63629
Product ID
63629-1998_e129c181-e65a-4dca-973b-cb395878be30
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 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
198368Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9584dd6e-cf8c-4c8b-b562-fcabcbf14a18Available 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
63629-1998-1Phenobarbital Sodium25 in 1 BOX, UNIT-DOSEINJECTION25105
63629-1998-2Phenobarbital Sodium1 mL in 1 VIALINJECTION1105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1998-1ML - Milliliter63629-19980536b241-bb98-4728-bf32-a61a4b9e999212021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1998PHENOBARBITAL SODIUM INJECTION [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240910_9584dd6e-cf8c-4c8b-b562-fcabcbf14a18.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 Prepack9584dd6e-cf8c-4c8b-b562-fcabcbf14a182025-08-18Warnings, Adverse reactionsExact identifier
ndc (package): 63629-1998-1
ndc (product): 63629-1998
ndc11 (package): 63629199801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198368PHENobarbital 65 MG/ML Injectable SolutionPSN9584dd6e-cf8c-4c8b-b562-fcabcbf14a18105
198368phenobarbital 65 MG/ML Injectable SolutionSCD9584dd6e-cf8c-4c8b-b562-fcabcbf14a18105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1998-16362919980125 VIAL in 1 BOX, UNIT-DOSE (63629-1998-1) / 1 mL in 1 VIAL (63629-1998-2) 25 vial2024-09-050000-00-00NoNoCurrent