FDA.reportPublic FDA data

Phenobarbital

Product NDC
75826-139
11-digit product format
758260139
Labeler code
75826
Product ID
75826-139_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
32.4 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
PHENOBARBITAL32.4 mg/1

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 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198083Internal RxNorm lookup
198086Internal RxNorm lookup
198089Internal RxNorm lookup
199164Internal RxNorm lookup
199167Internal RxNorm lookup
199168Internal RxNorm lookup
312357Internal RxNorm lookup
312362Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1805bc08-e870-4373-b290-bed1eed87df6Available 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
75826-139-00Phenobarbital1000 in 1 BOTTLE, PLASTICTABLET10005
75826-139-10Phenobarbital100 in 1 BOTTLE, PLASTICTABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75826-139-00EA - Each75826-1398746bfeb-e4f4-44ce-b2dd-ab06536c234a12019-07-02
75826-139-10EA - Each75826-139ea5b5a03-8170-4fe5-bb86-ba7d65ac6f5e12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-139PHENOBARBITAL TABLET [WINDER LABORATORIES, LLC]5Current NDC, Legacy NDC, 2 package rows20250108_1805bc08-e870-4373-b290-bed1eed87df6.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
PhenobarbitalPHENOBARBITALWINDER LABORATORIES, LLC1805bc08-e870-4373-b290-bed1eed87df62022-05-31Warnings, Adverse reactionsExact identifier
ndc (product): 75826-139

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75826-139-00758260139001000 TABLET in 1 BOTTLE, PLASTIC (75826-139-00) 1000 tablet2019-06-110000-00-00NoNoCurrent
75826-139-1075826013910100 TABLET in 1 BOTTLE, PLASTIC (75826-139-10) 100 tablet2019-06-110000-00-00NoNoCurrent