FDA.reportPublic FDA data

Phenobarbital

Product NDC
68999-962
11-digit product format
689990962
Labeler code
68999
Product ID
68999-962_4ba9b27e-0ef4-ea4c-e063-6394a90ab84a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenobarbital
Listing expiration
2027-12-31

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
68999-962-05Phenobarbital5 mL in 1 CUPSOLUTION52
68999-962-07Phenobarbital7.5 mL in 1 CUPSOLUTION7.52
68999-962-15Phenobarbital15 mL in 1 CUPSOLUTION152
68999-962-22Phenobarbital10 in 1 TRAYSOLUTION102
68999-962-22Phenobarbital2 in 1 BOXSOLUTION22
68999-962-23Phenobarbital10 in 1 TRAYSOLUTION102
68999-962-23Phenobarbital2 in 1 BOXSOLUTION22
68999-962-24Phenobarbital2 in 1 BOXSOLUTION22
68999-962-24Phenobarbital10 in 1 TRAYSOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-962-05ML - Milliliter68999-962e01fa165-eea6-4ab1-8459-d0eafed341a312026-04-20
68999-962-07ML - Milliliter68999-962eb93f3e3-e30e-4c36-b648-cbbfeb21804f12026-04-20
68999-962-15ML - Milliliter68999-962962e14d6-a27c-425a-9c22-21e623b87d6312026-04-20
68999-962-22ML - Milliliter68999-962d209fbae-4cd7-4b53-b72d-1d1d471bad1712026-04-20
68999-962-23ML - Milliliter68999-9628e09e350-614e-4f82-bcf5-f55cd8b7aa6e12026-04-20
68999-962-24ML - Milliliter68999-962de43f0f5-ee22-4a2e-a130-4863f16c7e8d12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN4616303e-1d91-4888-8156-4ae6bd3891b72
702519phenobarbital 4 MG/ML Oral SolutionSCD4616303e-1d91-4888-8156-4ae6bd3891b72
702519phenobarbital 20 MG per 5 ML Oral SolutionSY4616303e-1d91-4888-8156-4ae6bd3891b72
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY4616303e-1d91-4888-8156-4ae6bd3891b72
702519phenobarbital 60 MG per 15 ML Oral SolutionSY4616303e-1d91-4888-8156-4ae6bd3891b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-962-05689990962055 mL in 1 CUP5 mlHistorical
68999-962-07689990962077.5 mL in 1 CUP7.5 mlHistorical
68999-962-156899909621515 mL in 1 CUP15 mlHistorical
68999-962-22689990962222 TRAY in 1 BOX (68999-962-22) / 10 CUP in 1 TRAY / 15 mL in 1 CUP (68999-962-15) 2 tray2026-02-17NoNoHistorical
68999-962-23689990962232 TRAY in 1 BOX (68999-962-23) / 10 CUP in 1 TRAY / 7.5 mL in 1 CUP (68999-962-07) 2 tray2026-02-17NoNoHistorical
68999-962-24689990962242 TRAY in 1 BOX (68999-962-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-962-05) 2 tray2026-02-17NoNoHistorical