FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
71335-3004
11-digit product format
713353004
Labeler code
71335
Product ID
71335-3004_17606ca5-d8bb-4265-af71-20ab4c56114d
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
25757bb2-1b5b-4261-867b-aa3a30ab214bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3004-1Phenobarbital Sodium25 in 1 BOX, UNIT-DOSEINJECTION25100
71335-3004-2Phenobarbital Sodium1 mL in 1 VIALINJECTION1100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3004-1ML - Milliliter71335-300498bd95a3-54e9-435b-b46e-0c2ac4bd201112026-01-08

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 Prepack25757bb2-1b5b-4261-867b-aa3a30ab214b2025-11-05Warnings, Adverse reactionsExact identifier
ndc (product): 71335-3004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198368PHENobarbital 65 MG/ML Injectable SolutionPSN25757bb2-1b5b-4261-867b-aa3a30ab214b100
198368phenobarbital 65 MG/ML Injectable SolutionSCD25757bb2-1b5b-4261-867b-aa3a30ab214b100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3004-17133530040125 VIAL in 1 BOX, UNIT-DOSE (71335-3004-1) / 1 mL in 1 VIAL (71335-3004-2) 25 vial2025-11-05NoNoCurrent
71335-3004-2713353004021 mL in 1 VIAL1 mlHistorical