FDA.reportPublic FDA data

Phenobarbital Sodium

Product NDC
0641-0477
11-digit product format
006410477
Labeler code
0641
Product ID
0641-0477_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
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SW9M9BB5K3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198368Internal RxNorm lookup
312370Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ffcaa218-ed6a-4557-9645-b9a91128a214Available on FDA.report

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
0641-0477-21Phenobarbital Sodium1 mL in 1 VIALINJECTION15
0641-0477-25Phenobarbital Sodium25 in 1 CARTONINJECTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-0477-21ML - Milliliter0641-0477985f6d12-e011-490c-99fd-80162c41277b12012-07-24
0641-0477-25ML - Milliliter0641-0477b0904971-1cd1-4230-ada1-fe10784156d412012-07-24

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
0641-0477PHENOBARBITAL SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240412_ffcaa218-ed6a-4557-9645-b9a91128a214.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenobarbital SodiumPHENOBARBITAL SODIUMHikma Pharmaceuticals USA Inc.ffcaa218-ed6a-4557-9645-b9a91128a2142024-04-10Warnings, Adverse reactionsExact identifier
ndc (product): 0641-0477

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
0641-0477-21006410477211 mL in 1 VIAL1 mlHistorical
0641-0477-250064104772525 VIAL in 1 CARTON (0641-0477-25) / 1 mL in 1 VIAL (0641-0477-21) 25 vial1971-01-010000-00-00NoNoCurrent