FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
71335-2728
11-digit product format
713352728
Labeler code
71335
Product ID
71335-2728_ed278fa3-7b39-4739-93c3-807462ef7e16
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
2671207Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a31fcc70-00aa-4f43-affc-5c36db7a9ad3Available 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
71335-2728-1Phenobarbital Sodium1 mL in 1 VIALINJECTION1100
71335-2728-1Phenobarbital Sodium25 in 1 BOX, UNIT-DOSEINJECTION25100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2728-1ML - Milliliter71335-27281ac71465-fcbd-4601-bd00-34f8a73504f112025-09-12

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 Prepacka31fcc70-00aa-4f43-affc-5c36db7a9ad32025-07-29Warnings, Adverse reactionsExact identifier
ndc (product): 71335-2728

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671207PHENobarbital sodium 65 MG in 1 ML InjectionPSNa31fcc70-00aa-4f43-affc-5c36db7a9ad3100
26712071 ML phenobarbital sodium 65 MG/ML InjectionSCDa31fcc70-00aa-4f43-affc-5c36db7a9ad3100
2671207phenobarbital sodium 65 MG per 1 ML InjectionSYa31fcc70-00aa-4f43-affc-5c36db7a9ad3100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2728-17133527280125 VIAL in 1 BOX, UNIT-DOSE (71335-2728-1) / 1 mL in 1 VIAL25 vial2025-07-30NoNoCurrent