FDA.reportPublic FDA data

Phenobarbital

Product NDC
75826-141
11-digit product format
758260141
Labeler code
75826
Product ID
75826-141_2b0ed16e-a65d-bed5-e063-6394a90aa05e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
WINDER LABORATORIES, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-06-11
Substance
PHENOBARBITAL
Active strength
64.8 mg/1
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
PHENOBARBITAL64.8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D
Rxcui198083, 198086, 198089, 199164, 199167, 199168, 312357, 312362

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
75826-141-00Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET10005
75826-141-10Phenobarbital100 in 1 BOTTLE, PLASTICTABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75826-141-00EA - Each75826-141605db5a6-dc3a-4bad-bd9b-797fdc292daf12019-07-02
75826-141-10EA - Each75826-141b9cdf263-1508-4463-b4a7-f7ab006ca46412019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-141PHENOBARBITAL TABLET [WINDER LABORATORIES, LLC]5Current NDC, Legacy NDC, 2 package rows20250108_1805bc08-e870-4373-b290-bed1eed87df6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198083PHENobarbital 100 MG Oral TabletPSN1805bc08-e870-4373-b290-bed1eed87df65
312357PHENobarbital 15 MG Oral TabletPSN1805bc08-e870-4373-b290-bed1eed87df65
198086PHENobarbital 16.2 MG Oral TabletPSN1805bc08-e870-4373-b290-bed1eed87df65
312362PHENobarbital 30 MG Oral TabletPSN1805bc08-e870-4373-b290-bed1eed87df65
199167PHENobarbital 32.4 MG Oral TabletPSN1805bc08-e870-4373-b290-bed1eed87df65
198089PHENobarbital 60 MG Oral TabletPSN1805bc08-e870-4373-b290-bed1eed87df65
199168PHENobarbital 64.8 MG Oral TabletPSN1805bc08-e870-4373-b290-bed1eed87df65
199164PHENobarbital 97.2 MG Oral TabletPSN1805bc08-e870-4373-b290-bed1eed87df65
198083phenobarbital 100 MG Oral TabletSCD1805bc08-e870-4373-b290-bed1eed87df65
312357phenobarbital 15 MG Oral TabletSCD1805bc08-e870-4373-b290-bed1eed87df65
198086phenobarbital 16.2 MG Oral TabletSCD1805bc08-e870-4373-b290-bed1eed87df65
312362phenobarbital 30 MG Oral TabletSCD1805bc08-e870-4373-b290-bed1eed87df65
199167phenobarbital 32.4 MG Oral TabletSCD1805bc08-e870-4373-b290-bed1eed87df65
198089phenobarbital 60 MG Oral TabletSCD1805bc08-e870-4373-b290-bed1eed87df65
199168phenobarbital 64.8 MG Oral TabletSCD1805bc08-e870-4373-b290-bed1eed87df65
199164phenobarbital 97.2 MG Oral TabletSCD1805bc08-e870-4373-b290-bed1eed87df65
199168PHENobarbital 64.8 MG Oral TabletPSN38f738a5-1c2f-b404-e063-6294a90a98791
199168phenobarbital 64.8 MG Oral TabletSCD38f738a5-1c2f-b404-e063-6294a90a98791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75826-141-00758260141001000 TABLET in 1 BOTTLE, PLASTIC (75826-141-00) 1000 tablet2019-06-110000-00-00NoNoCurrent
75826-141-1075826014110100 TABLET in 1 BOTTLE, PLASTIC (75826-141-10) 100 tablet2019-06-110000-00-00NoNoCurrent