FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
42494-416
11-digit product format
424940416
Labeler code
42494
Product ID
42494-416_f69a86e8-b217-47eb-b536-2b5677cfe85f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Cameron Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-02-05
Substance
PHENOBARBITAL SODIUM
Active strength
130 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 SODIUM130 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42494-416-032023-10-27C16284748780-1d6a99b39-530e-a426-e053-dadaa90af4c2Phenobarbital Sodium Injection, USP
42494-416-252023-10-27C16284748780-1d6a99b39-530e-a426-e053-dadaa90af4c2Phenobarbital Sodium Injection, USP
42494-416-032022-01-28C16284748780-1d6a99b39-530e-a426-e053-dadaa90af4c2Phenobarbital Sodium Injection, USP
42494-416-252022-01-28C16284748780-1d6a99b39-530e-a426-e053-dadaa90af4c2Phenobarbital Sodium Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42494-416-03Phenobarbital Sodium1 mL in 1 VIALINJECTION15
42494-416-03Phenobarbital Sodium3 in 1 BOX, UNIT-DOSEINJECTION35
42494-416-25Phenobarbital Sodium1 mL in 1 VIALINJECTION15
42494-416-25Phenobarbital Sodium25 in 1 BOX, UNIT-DOSEINJECTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42494-416-03ML - Milliliter42494-416be66733b-c621-465d-a0b9-92ec37b1288412020-05-08
42494-416-25ML - Milliliter42494-416427293c7-a467-4e9c-b309-cfc15032ecf712020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42494-416PHENOBARBITAL SODIUM INJECTION [CAMERON PHARMACEUTICALS]4Current NDC, Legacy NDC, 4 package rows20240820_50e73787-ede1-4839-aaa5-806e25f18b1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2671204PHENobarbital sodium 130 MG in 1 ML InjectionPSN6ae7dda0-a1c8-4aad-a2b2-36a26ca35713109
26712041 ML phenobarbital sodium 130 MG/ML InjectionSCD6ae7dda0-a1c8-4aad-a2b2-36a26ca35713109
2671204phenobarbital sodium 130 MG per 1 ML InjectionSY6ae7dda0-a1c8-4aad-a2b2-36a26ca35713109
312370PHENobarbital 130 MG/ML Injectable SolutionPSN860d9c27-9c73-4d2c-bc31-a37472a38f7c105
312370phenobarbital 130 MG/ML Injectable SolutionSCD860d9c27-9c73-4d2c-bc31-a37472a38f7c105
312370PHENobarbital 130 MG/ML Injectable SolutionPSN94673663-cf49-42ad-a201-09195b8d4e5b100
2671204PHENobarbital sodium 130 MG in 1 ML InjectionPSN62869848-3914-45f0-a191-93cdf403b0ae100
26712041 ML phenobarbital sodium 130 MG/ML InjectionSCD62869848-3914-45f0-a191-93cdf403b0ae100
312370phenobarbital 130 MG/ML Injectable SolutionSCD94673663-cf49-42ad-a201-09195b8d4e5b100
2671204phenobarbital sodium 130 MG per 1 ML InjectionSY62869848-3914-45f0-a191-93cdf403b0ae100
2671204PHENobarbital sodium 130 MG in 1 ML InjectionPSN50e73787-ede1-4839-aaa5-806e25f18b1a5
2671207PHENobarbital sodium 65 MG in 1 ML InjectionPSN50e73787-ede1-4839-aaa5-806e25f18b1a5
26712041 ML phenobarbital sodium 130 MG/ML InjectionSCD50e73787-ede1-4839-aaa5-806e25f18b1a5
26712071 ML phenobarbital sodium 65 MG/ML InjectionSCD50e73787-ede1-4839-aaa5-806e25f18b1a5
2671204phenobarbital sodium 130 MG per 1 ML InjectionSY50e73787-ede1-4839-aaa5-806e25f18b1a5
2671207phenobarbital sodium 65 MG per 1 ML InjectionSY50e73787-ede1-4839-aaa5-806e25f18b1a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42494-416-03424940416033 VIAL in 1 BOX, UNIT-DOSE (42494-416-03) / 1 mL in 1 VIAL3 vial2020-02-050000-00-00NoNoCurrent
42494-416-254249404162525 VIAL in 1 BOX, UNIT-DOSE (42494-416-25) / 1 mL in 1 VIAL25 vial2020-02-050000-00-00NoNoCurrent