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 Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui702519

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

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 tray2025-02-13NoNoHistorical
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 tray2025-02-13NoNoHistorical
62135-962-24621350962242 TRAY in 1 BOX (62135-962-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-962-05) 2 tray2025-02-13NoNoHistorical
62135-962-4762135096247473 mL in 1 BOTTLE (62135-962-47) 473 ml2025-02-13NoNoHistorical