FDA.reportPublic FDA data

Stavudine

Product NDC
53808-0595
11-digit product format
538080595
Labeler code
53808
Product ID
53808-0595_8a5e45f3-462d-4f86-b06b-4df7ca2da01e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Stavudine
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA078957
Marketing category
ANDA
Marketing start
2009-07-01
Marketing end
0000-00-00
Substance
STAVUDINE
Active strength
40 mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f7bbe6f-8bb8-eee9-cb0e-a5f4e0b695d8Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0595-12020-01-31C16284748780-19d75b9d0-756d-f424-e053-dadaa90a57ce081991e0-eee4-4fa3-ac3d-0c32cb03e7f3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0595-1Stavudine30 in 1 BLISTER PACKCAPSULE301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STAVUDINEACTIVE INGREDIENTBO9LE4QFZFSTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STAVUDINEACTIVE MOIETYBO9LE4QFZFSTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LSTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2STAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0595STAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100614_081991e0-eee4-4fa3-ac3d-0c32cb03e7f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313110stavudine 40 MG Oral CapsulePSN081991e0-eee4-4fa3-ac3d-0c32cb03e7f31
313110stavudine 40 MG Oral CapsuleSCD081991e0-eee4-4fa3-ac3d-0c32cb03e7f31
313110D4T 40 MG Oral CapsuleSY081991e0-eee4-4fa3-ac3d-0c32cb03e7f31
313110DHT 40 MG Oral CapsuleSY081991e0-eee4-4fa3-ac3d-0c32cb03e7f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0595-15380805950130 in 1 BLISTER PACKHistorical