FDA.reportPublic FDA data

Phenobarbital

Product NDC
62135-962
11-digit product format
621350962
Labeler code
62135
Product ID
62135-962_30532bf0-5dc2-4d1b-e063-6394a90a119a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-02-13
Substance
PHENOBARBITAL
Active strength
20 mg/5mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL20 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YQE403BP4DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
702519Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
feda8ef8-6d67-4ea1-bf19-21fd7d4872bdAvailable 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
62135-962-05Phenobarbital5 mL in 1 CUPSOLUTION51
62135-962-07Phenobarbital7.5 mL in 1 CUPSOLUTION7.51
62135-962-15Phenobarbital15 mL in 1 CUPSOLUTION151
62135-962-22Phenobarbital10 in 1 TRAYSOLUTION101
62135-962-22Phenobarbital2 in 1 BOXSOLUTION21
62135-962-23Phenobarbital2 in 1 BOXSOLUTION21
62135-962-23Phenobarbital10 in 1 TRAYSOLUTION101
62135-962-24Phenobarbital2 in 1 BOXSOLUTION21
62135-962-24Phenobarbital10 in 1 TRAYSOLUTION101
62135-962-47Phenobarbital473 mL in 1 BOTTLESOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-962-05ML - Milliliter62135-962f5abcd91-8788-40f4-959a-b2e6145cfe2d12025-05-14
62135-962-07ML - Milliliter62135-96273d30b12-ec55-4282-a745-9d35595f60c512025-05-14
62135-962-15ML - Milliliter62135-962dbe91640-1022-4b1e-980e-8ffcc8f568b712025-05-14
62135-962-22ML - Milliliter62135-9621404e8a8-f843-426f-9e1d-a40e8ea62d9312025-05-14
62135-962-23ML - Milliliter62135-962be526f3a-a6e8-4ba6-93ad-9fb2e9db76a612025-05-14
62135-962-24ML - Milliliter62135-962eb6f7efe-cf7a-4750-99a4-4631668ae05812025-05-14
62135-962-47ML - Milliliter62135-96218f4263b-5024-4e24-a0aa-d7724435559b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-962PHENOBARBITAL SOLUTION [CHARTWELL RX, LLC]1Current NDC, 10 package rows20250316_feda8ef8-6d67-4ea1-bf19-21fd7d4872bd.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
PhenobarbitalPHENOBARBITALChartwell RX, LLCfeda8ef8-6d67-4ea1-bf19-21fd7d4872bd2025-03-14Warnings, Adverse reactionsExact identifier
ndc (product): 62135-962

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSNfeda8ef8-6d67-4ea1-bf19-21fd7d4872bd1
702519phenobarbital 4 MG/ML Oral SolutionSCDfeda8ef8-6d67-4ea1-bf19-21fd7d4872bd1
702519phenobarbital 20 MG per 5 ML Oral SolutionSYfeda8ef8-6d67-4ea1-bf19-21fd7d4872bd1
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSYfeda8ef8-6d67-4ea1-bf19-21fd7d4872bd1
702519phenobarbital 60 MG per 15 ML Oral SolutionSYfeda8ef8-6d67-4ea1-bf19-21fd7d4872bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-962-05621350962055 mL in 1 CUP5 mlHistorical
62135-962-07621350962077.5 mL in 1 CUP7.5 mlHistorical
62135-962-156213509621515 mL in 1 CUP15 mlHistorical
62135-962-22621350962222 TRAY in 1 BOX (62135-962-22) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (62135-962-15) 2 tray2025-02-13NoNoCurrent
62135-962-23621350962232 TRAY in 1 BOX (62135-962-23) / 10 CUP in 1 TRAY / 7.5 mL in 1 CUP (62135-962-07) 2 tray2025-02-13NoNoCurrent
62135-962-24621350962242 TRAY in 1 BOX (62135-962-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-962-05) 2 tray2025-02-13NoNoCurrent
62135-962-4762135096247473 mL in 1 BOTTLE (62135-962-47) 473 ml2025-02-13NoNoCurrent