FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
0641-0476
11-digit product format
006410476
Labeler code
0641
Product ID
0641-0476_57a9cc7f-aead-4434-942f-363a419ea385
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital Sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1971-01-01
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
Rxcui198368, 312370

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
0641-0476-21Phenobarbital Sodium1 mL in 1 VIALINJECTION15
0641-0476-25Phenobarbital Sodium25 in 1 CARTONINJECTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-0476-21ML - Milliliter0641-0476d8ca8854-7b41-473a-af10-c510e05f47b712012-07-24
0641-0476-25ML - Milliliter0641-047697d60646-cbfd-40a9-9e70-f8d85d99580a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENOBARBITAL SODIUMACTIVE INGREDIENTSW9M9BB5K3PHENOBARBITAL SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
PHENOBARBITALACTIVE MOIETYYQE403BP4DPHENOBARBITAL SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENOBARBITAL SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPHENOBARBITAL SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPHENOBARBITAL SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENOBARBITAL SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RPHENOBARBITAL SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-0476PHENOBARBITAL SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240412_ffcaa218-ed6a-4557-9645-b9a91128a214.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312370PHENobarbital 130 MG/ML Injectable SolutionPSNffcaa218-ed6a-4557-9645-b9a91128a2145
198368PHENobarbital 65 MG/ML Injectable SolutionPSNffcaa218-ed6a-4557-9645-b9a91128a2145
312370phenobarbital 130 MG/ML Injectable SolutionSCDffcaa218-ed6a-4557-9645-b9a91128a2145
198368phenobarbital 65 MG/ML Injectable SolutionSCDffcaa218-ed6a-4557-9645-b9a91128a2145

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-0476-21006410476211 mL in 1 VIAL1 mlHistorical
0641-0476-250064104762525 VIAL in 1 CARTON (0641-0476-25) / 1 mL in 1 VIAL (0641-0476-21) 25 vial1971-01-010000-00-00NoNoCurrent