Phenobarbital Sodium

Product NDC
42494-442
11-digit product format
424940442
Labeler code
42494
Product ID
42494-442_c8fe78ce-36e8-45f2-b23e-9dc6d62d56b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOBARBITAL SODIUM
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Cameron Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-06-02
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
Rxcui198368, 312370

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
42494-442-252025-02-11C16284748780-12cef2736-6966-d83d-e063-dadaa90ab31fPhenobarbital Sodium Injection, USP
42494-442-252025-01-30C16284748780-12cef2736-6966-d83d-e063-dadaa90ab31fPhenobarbital Sodium Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42494-442-25Phenobarbital Sodium1 mL in 1 VIALINJECTION13
42494-442-25Phenobarbital Sodium3 in 1 BOX, UNIT-DOSEINJECTION33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42494-442-25ML - Milliliter42494-4428d154ecd-72e4-40f5-921f-bfb3b02106a912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42494-442PHENOBARBITAL SODIUM INJECTION [CAMERON PHARMACEUTICALS]2Current NDC, 2 package rows20250213_9091250d-694a-4593-84dc-6fe54aef495f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312370PHENobarbital 130 MG/ML Injectable SolutionPSN9091250d-694a-4593-84dc-6fe54aef495f3
198368PHENobarbital 65 MG/ML Injectable SolutionPSN9091250d-694a-4593-84dc-6fe54aef495f3
312370phenobarbital 130 MG/ML Injectable SolutionSCD9091250d-694a-4593-84dc-6fe54aef495f3
198368phenobarbital 65 MG/ML Injectable SolutionSCD9091250d-694a-4593-84dc-6fe54aef495f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42494-442-25424940442253 VIAL in 1 BOX, UNIT-DOSE (42494-442-25) / 1 mL in 1 VIAL3 vial2023-06-02NoNoCurrent