FDA.reportPublic FDA data

Ursodiol

Product NDC
0527-1326
11-digit product format
005271326
Labeler code
0527
Product ID
0527-1326_2a1b76c4-6aa9-4132-ae02-177791eb7560
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ursodiol
Dosage form
CAPSULE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA079082
Marketing category
ANDA
Marketing start
2009-01-01
Substance
URSODIOL
Active strength
300 mg/1
Pharmacologic classes
Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ursodiol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
URSODIOL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii724L30Y2QR
Rxcui858747

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ab35ce6-695f-4d1d-43b4-c16fd63c1674Product name320250317
74e0d644-a165-40ec-b881-1b01c8aa68a4Product name120201006
24881a03-c677-697f-03b9-66e93689fadeProduct name220180724

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-1326-012024-01-30C16284748780-11030e365-5f1e-111a-e063-dadaa90a10e2Ursodiol Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1326-01Ursodiol100 in 1 BOTTLECAPSULE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1326-01EA - Each0527-132630aa4c1e-485c-47b2-baa2-b7c286d4711412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
URSODIOLACTIVE INGREDIENT724L30Y2QRURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
URSODIOLACTIVE MOIETY724L30Y2QRURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933URSODIOL CAPSULE [LANNETT COMPANY, INC.]6
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3URSODIOL CAPSULE [LANNETT COMPANY, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8URSODIOL CAPSULE [LANNETT COMPANY, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357URSODIOL CAPSULE [LANNETT COMPANY, INC.]6
GELATININACTIVE INGREDIENT2G86QN327LURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30URSODIOL CAPSULE [LANNETT COMPANY, INC.]6
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15URSODIOL CAPSULE [LANNETT COMPANY, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3URSODIOL CAPSULE [LANNETT COMPANY, INC.]6
SHELLACINACTIVE INGREDIENT46N107B71OURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4URSODIOL CAPSULE [LANNETT COMPANY, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPURSODIOL CAPSULE [LANNETT COMPANY, INC.]6
URSODIOLACTIVE INGREDIENT724L30Y2QRURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
URSODIOLACTIVE MOIETY724L30Y2QRURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
GELATININACTIVE INGREDIENT2G86QN327LURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
SHELLACINACTIVE INGREDIENT46N107B71OURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4URSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPURSODIOL CAPSULE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1326URSODIOL CAPSULE [LANNETT COMPANY, INC.]15Current NDC, Legacy NDC, 1 package rows20240704_2e799e93-b5a0-40f7-95c5-b40d8a948a0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
858747ursodiol 300 MG Oral CapsulePSN2e799e93-b5a0-40f7-95c5-b40d8a948a0d15
858747ursodiol 300 MG Oral CapsuleSCD2e799e93-b5a0-40f7-95c5-b40d8a948a0d15
858747ursodiol 300 MG Oral CapsulePSN9ae9412b-36d5-4634-8d5c-cc96110821c010
858747ursodiol 300 MG Oral CapsuleSCD9ae9412b-36d5-4634-8d5c-cc96110821c010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1326-0100527132601100 CAPSULE in 1 BOTTLE (0527-1326-01) 100 capsule2009-01-010000-00-00NoNoCurrent