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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42494-416-03fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42494-416-25fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42494-416-0386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42494-416-2586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42494-416-03bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42494-416-25bd6a592717d7…303034d00443…

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
2671204Internal RxNorm lookup
2671207Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
50e73787-ede1-4839-aaa5-806e25f18b1aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912

FDA-Initiated Inactive NDC Indexing#

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

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 SODIUMCameron Pharmaceuticals50e73787-ede1-4839-aaa5-806e25f18b1a2025-06-04Warnings, Adverse reactionsExact identifier
ndc (product): 42494-416

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