FDA.reportPublic FDA data

Lithostat

Product NDC
0178-0500
11-digit product format
001780500
Labeler code
0178
Product ID
0178-0500_47e7b4dd-b3b1-f6a0-e063-6294a90a1bca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetohydroxamic acid
Dosage form
TABLET
Route
ORAL
Labeler
Mission Pharmacal Company
Application
NDA018749
Marketing category
NDA
Marketing start
1983-05-31
Substance
ACETOHYDROXAMIC ACID
Active strength
250 mg/1
Pharmacologic classes
Urease Inhibitor [EPC], Urease Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lithostat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETOHYDROXAMIC ACID250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4RZ82L2GY5
Rxcui197308, 213557

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
69d53c56-a4c7-54ae-c338-8d2086506799Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0178-0500-012020-06-22C16284748780-19d75b9d0-f9bb-f424-e053-dadaa90a57ceLITHOSTAT ® (Acetohydroxamic Acid) Tablets
0178-0500-012020-06-22C16284748780-19d75b9d0-f9bb-f424-e053-dadaa90a57ceLITHOSTAT ® (Acetohydroxamic Acid) Tablets
0178-0500-012020-01-31C16284748780-19d75b9d0-f9bb-f424-e053-dadaa90a57ceLITHOSTAT ® (Acetohydroxamic Acid) Tablets
0178-0500-012020-01-31C16284748780-19d75b9d0-f9bb-f424-e053-dadaa90a57ceLITHOSTAT ® (Acetohydroxamic Acid) Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0500-01Lithostat100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0500-01EA - Each0178-05006ad63b6f-30ec-4e43-b3f6-361cfbf8a8f512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETOHYDROXAMIC ACIDACTIVE INGREDIENT4RZ82L2GY5LITHOSTAT (ACETOHYDROXAMIC ACID) TABLET [MISSION PHARMACAL COMPANY]1
ACETOHYDROXAMIC ACIDACTIVE MOIETY4RZ82L2GY5LITHOSTAT (ACETOHYDROXAMIC ACID) TABLET [MISSION PHARMACAL COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULITHOSTAT (ACETOHYDROXAMIC ACID) TABLET [MISSION PHARMACAL COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LITHOSTAT (ACETOHYDROXAMIC ACID) TABLET [MISSION PHARMACAL COMPANY]1
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHLITHOSTAT (ACETOHYDROXAMIC ACID) TABLET [MISSION PHARMACAL COMPANY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LITHOSTAT (ACETOHYDROXAMIC ACID) TABLET [MISSION PHARMACAL COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0500LITHOSTAT (ACETOHYDROXAMIC ACID) TABLET [MISSION PHARMACAL COMPANY]6Current NDC, Legacy NDC, 1 package rows20240110_6660b616-a82d-9109-19ce-2bdf9747acea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197308acetohydroxamic acid 250 MG Oral TabletPSN6660b616-a82d-9109-19ce-2bdf9747acea7
213557Lithostat 250 MG Oral TabletPSN6660b616-a82d-9109-19ce-2bdf9747acea7
213557acetohydroxamic acid 250 MG Oral Tablet [Lithostat]SBD6660b616-a82d-9109-19ce-2bdf9747acea7
197308acetohydroxamic acid 250 MG Oral TabletSCD6660b616-a82d-9109-19ce-2bdf9747acea7
213557Lithostat 250 MG Oral TabletSY6660b616-a82d-9109-19ce-2bdf9747acea7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0500-0100178050001100 TABLET in 1 BOTTLE (0178-0500-01) 100 tablet1983-05-310000-00-00NoNoCurrent