FDA.reportPublic FDA data

Phenobarbital

Product NDC
13811-299
11-digit product format
138110299
Labeler code
13811
Product ID
13811-299_bcb25645-8c32-48a6-be08-1e6d72cc5c50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
ELIXIR
Route
ORAL
Labeler
Trigen Laboratories, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-05-05
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13811-299-08Phenobarbital473 mL in 1 BOTTLE, PLASTICELIXIR4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-299-08ML - Milliliter13811-2990e1737d7-ea7d-4e2d-affb-094b77f16bbb12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13811-299PHENOBARBITAL ELIXIR [TRIGEN LABORATORIES, LLC]1Current NDC, 1 package rows20250506_057992c1-29a0-4229-9c30-d787cb632eac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702519PHENobarbital 20 MG in 5 mL Oral SolutionPSN057992c1-29a0-4229-9c30-d787cb632eac2
702519phenobarbital 4 MG/ML Oral SolutionSCD057992c1-29a0-4229-9c30-d787cb632eac2
702519phenobarbital 20 MG per 5 ML Oral SolutionSY057992c1-29a0-4229-9c30-d787cb632eac2
702519phenobarbital 30 MG per 7.5 ML Oral SolutionSY057992c1-29a0-4229-9c30-d787cb632eac2
702519phenobarbital 60 MG per 15 ML Oral SolutionSY057992c1-29a0-4229-9c30-d787cb632eac2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13811-299-0813811029908473 mL in 1 BOTTLE, PLASTIC (13811-299-08) 473 ml2025-05-05NoNoHistorical