FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
63629-2008
11-digit product format
636292008
Labeler code
63629
Product ID
63629-2008_6a01d4e0-f324-4cd0-9e6c-75486937a837
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-2008DDiscontinued by firm2026-08-11
excluded packagepackage63629-200863629-2008-1DDiscontinued by firm2026-08-11

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
63629-2008-1Phenobarbital Sodium3 in 1 BOX, UNIT-DOSEINJECTION3105
63629-2008-2Phenobarbital Sodium1 mL in 1 VIALINJECTION1105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2008-1ML - Milliliter63629-20083d05a4f2-d9e4-4c36-9d95-cdf610dbbe3c12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2008PHENOBARBITAL SODIUM INJECTION [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240912_549ddfb4-576b-4dc9-8f38-48acf906bae5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198368PHENobarbital 65 MG/ML Injectable SolutionPSN549ddfb4-576b-4dc9-8f38-48acf906bae5105
198368phenobarbital 65 MG/ML Injectable SolutionSCD549ddfb4-576b-4dc9-8f38-48acf906bae5105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2008-1636292008013 VIAL in 1 BOX, UNIT-DOSE (63629-2008-1) / 1 mL in 1 VIAL (63629-2008-2) 3 vial2024-09-050000-00-00NoNoCurrent
63629-2008-2636292008021 mL in 1 VIAL1 mlHistorical