FDA.reportPublic FDA data

Chenodiol

Product NDC
79739-7121
Requested package NDC
79739-7121-1
11-digit product format
797397121
Labeler code
79739
Product ID
79739-7121_d35752ce-bbf7-4690-bf1e-bd024fba85e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chenodiol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
LGM Pharma Solutions, LLC
Application
ANDA091019
Marketing category
ANDA
Marketing start
2009-10-22
Marketing end
0000-00-00
Substance
CHENODIOL
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage79739-712179739-7121-1IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091019-001CHENODIOLCHENODIOL250MGTABLET / ORALRS2009-10-22

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A091019-001CHENODIOL250MGTABLET / ORALRS2009-10-22a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChenodalCHENODIOLTravere Therapeutics769e0a3b-826d-4faf-9129-5eeb7ebe0b672025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091019
application number: ANDA091019

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b2a75fa-5ed0-4686-af9b-1aa5557c6ac7Product name120251121
fccc16f3-c653-cdf3-e7bb-6ca4495099eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79739-7121-12025-01-30C16284748780-1d6a99b39-936a-a426-e053-dadaa90af4c2Chenodiol
79739-7121-12023-04-28C16284748780-1d6a99b39-936a-a426-e053-dadaa90af4c2Chenodiol
79739-7121-12022-01-28C16284748780-1d6a99b39-936a-a426-e053-dadaa90af4c2Chenodiol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79739-7121-1Chenodiol1 in 1 BOTTLE, PLASTICTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79739-7121CHENODIOL TABLET, FILM COATED [LGM PHARMA SOLUTIONS, LLC]2Legacy NDC, 1 package rows20230429_d35752ce-bbf7-4690-bf1e-bd024fba85e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
618469chenodiol 250 MG Oral TabletPSNd35752ce-bbf7-4690-bf1e-bd024fba85e22
618469chenodeoxycholate 250 MG Oral TabletSCDd35752ce-bbf7-4690-bf1e-bd024fba85e22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
79739-7121-1797397121011 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (79739-7121-1) 2009-10-220000-00-00NoNoCurrent