FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
14789-127
11-digit product format
147890127
Labeler code
14789
Product ID
14789-127_45c7f956-27bd-dc6d-e063-6394a90a6181
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Nexus Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-06
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 Identifiers#

Field, Values table
FieldValues
UniiSW9M9BB5K3
Rxcui2671204, 2671207

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
14789-127-05Phenobarbital Sodium10 in 1 CARTONINJECTION, SOLUTION106
14789-127-07Phenobarbital Sodium1 mL in 1 VIAL, GLASSINJECTION, SOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14789-127-05ML - Milliliter14789-1276d37864e-e797-4cab-b520-26d7b7edf95812024-02-14
14789-127-07ML - Milliliter14789-12740a72ec8-6772-461d-947a-fcda3efc7d2312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14789-127PHENOBARBITAL SODIUM INJECTION, SOLUTION [NEXUS PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20241211_472da201-698e-4d2b-8c53-595461d85bb6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671204PHENobarbital sodium 130 MG in 1 ML InjectionPSN472da201-698e-4d2b-8c53-595461d85bb66
2671207PHENobarbital sodium 65 MG in 1 ML InjectionPSN472da201-698e-4d2b-8c53-595461d85bb66
26712041 ML phenobarbital sodium 130 MG/ML InjectionSCD472da201-698e-4d2b-8c53-595461d85bb66
26712071 ML phenobarbital sodium 65 MG/ML InjectionSCD472da201-698e-4d2b-8c53-595461d85bb66
2671204phenobarbital sodium 130 MG per 1 ML InjectionSY472da201-698e-4d2b-8c53-595461d85bb66
2671207phenobarbital sodium 65 MG per 1 ML InjectionSY472da201-698e-4d2b-8c53-595461d85bb66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14789-127-051478901270510 VIAL, GLASS in 1 CARTON (14789-127-05) / 1 mL in 1 VIAL, GLASS (14789-127-07) 2025-12-310000-00-00NoNoCurrent
14789-127-07147890127071 mL in 1 VIAL, GLASS1 mlHistorical