SEZABY

Product NDC
62756-301
11-digit product format
627560301
Labeler code
62756
Product ID
62756-301_842763a1-63ca-4721-b127-f997ac4aa659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital sodium
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA215910
Marketing category
NDA
Marketing start
2022-12-25
Substance
PHENOBARBITAL SODIUM
Active strength
100 mg/1
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
SEZABY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSW9M9BB5K3
Rxcui2624719, 2624724

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
62756-301-01SEZABY1 in 1 VIAL, SINGLE-DOSEINJECTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-301-01EA - Each62756-301c2027044-61ff-4f5e-9df0-553d98d14b4012023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-301SEZABY (PHENOBARBITAL SODIUM) INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 1 package rows20240927_8c7d0402-4977-4c25-bc4b-11db91339e9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2624719PHENobarbital sodium 100 MG InjectionPSN8c7d0402-4977-4c25-bc4b-11db91339e9a7
2624724Sezaby 100 MG InjectionPSN8c7d0402-4977-4c25-bc4b-11db91339e9a7
2624724phenobarbital sodium 100 MG Injection [Sezaby]SBD8c7d0402-4977-4c25-bc4b-11db91339e9a7
2624719phenobarbital sodium 100 MG InjectionSCD8c7d0402-4977-4c25-bc4b-11db91339e9a7
2624724Sezaby 100 MG InjectionSY8c7d0402-4977-4c25-bc4b-11db91339e9a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-301-01627560301011 INJECTION in 1 VIAL, SINGLE-DOSE (62756-301-01) 1 injection2022-12-260000-00-00NoNoCurrent