FDA.reportPublic FDA data

Phenobarbital

Product NDC
16571-671
11-digit product format
165710671
Labeler code
16571
Product ID
16571-671_9abc9dc4-1a62-480d-a0a9-fad16c154eae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenobarbital
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-11-01
Substance
PHENOBARBITAL
Active strength
16.2 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
PHENOBARBITAL16.2 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198086Internal RxNorm lookup
199164Internal RxNorm lookup
199167Internal RxNorm lookup
199168Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9abc9dc4-1a62-480d-a0a9-fad16c154eaeAvailable 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
16571-671-01Phenobarbital100 in 1 BOTTLETABLET1001
16571-671-10Phenobarbital1000 in 1 BOTTLETABLET10001
16571-671-50Phenobarbital500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-671PHENOBARBITAL TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, Legacy NDC, 3 package rows20201117_9abc9dc4-1a62-480d-a0a9-fad16c154eae.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
PhenobarbitalPHENOBARBITALRising Pharma Holdings, Inc.9abc9dc4-1a62-480d-a0a9-fad16c154eae2020-07-01Warnings, Adverse reactionsExact identifier
ndc (product): 16571-671

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198086PHENobarbital 16.2 MG Oral TabletPSN2c238b77-6806-44af-9a66-fd871eaddfc0102
198086PHENobarbital 16.2 MG Oral TabletPSNee6c3196-becf-439d-9e22-70d82bd94365102
198086PHENobarbital 16.2 MG Oral TabletPSNe1709a49-ee44-4679-9a57-a7ea85a78ab7102
198086phenobarbital 16.2 MG Oral TabletSCDee6c3196-becf-439d-9e22-70d82bd94365102
198086phenobarbital 16.2 MG Oral TabletSCD2c238b77-6806-44af-9a66-fd871eaddfc0102
198086phenobarbital 16.2 MG Oral TabletSCDe1709a49-ee44-4679-9a57-a7ea85a78ab7102
198086PHENobarbital 16.2 MG Oral TabletPSN9abc9dc4-1a62-480d-a0a9-fad16c154eae1
198086PHENobarbital 16.2 MG Oral TabletPSN47b5e7d0-f031-4f6c-a496-c92f9f972f531
199167PHENobarbital 32.4 MG Oral TabletPSN47b5e7d0-f031-4f6c-a496-c92f9f972f531
199167PHENobarbital 32.4 MG Oral TabletPSN9abc9dc4-1a62-480d-a0a9-fad16c154eae1
199168PHENobarbital 64.8 MG Oral TabletPSN47b5e7d0-f031-4f6c-a496-c92f9f972f531
199168PHENobarbital 64.8 MG Oral TabletPSN9abc9dc4-1a62-480d-a0a9-fad16c154eae1
199164PHENobarbital 97.2 MG Oral TabletPSN9abc9dc4-1a62-480d-a0a9-fad16c154eae1
199164PHENobarbital 97.2 MG Oral TabletPSN47b5e7d0-f031-4f6c-a496-c92f9f972f531
198086phenobarbital 16.2 MG Oral TabletSCD9abc9dc4-1a62-480d-a0a9-fad16c154eae1
198086phenobarbital 16.2 MG Oral TabletSCD47b5e7d0-f031-4f6c-a496-c92f9f972f531
199167phenobarbital 32.4 MG Oral TabletSCD47b5e7d0-f031-4f6c-a496-c92f9f972f531
199167phenobarbital 32.4 MG Oral TabletSCD9abc9dc4-1a62-480d-a0a9-fad16c154eae1
199168phenobarbital 64.8 MG Oral TabletSCD47b5e7d0-f031-4f6c-a496-c92f9f972f531
199168phenobarbital 64.8 MG Oral TabletSCD9abc9dc4-1a62-480d-a0a9-fad16c154eae1
199164phenobarbital 97.2 MG Oral TabletSCD9abc9dc4-1a62-480d-a0a9-fad16c154eae1
199164phenobarbital 97.2 MG Oral TabletSCD47b5e7d0-f031-4f6c-a496-c92f9f972f531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-671-0116571067101100 TABLET in 1 BOTTLE (16571-671-01) 100 tablet2020-11-010000-00-00NoNoCurrent
16571-671-10165710671101000 TABLET in 1 BOTTLE (16571-671-10) 1000 tablet2020-11-010000-00-00NoNoCurrent
16571-671-5016571067150500 TABLET in 1 BOTTLE (16571-671-50) 500 tablet2020-11-010000-00-00NoNoCurrent