FDA.reportPublic FDA data

Stavudine

Product NDC
53808-0852
11-digit product format
538080852
Labeler code
53808
Product ID
53808-0852_5f18c60b-648b-404a-858f-00ddaa9b0be1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
stavudine
Dosage form
CAPSULE
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA079069
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
STAVUDINE
Active strength
20 mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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
53808-0852-12020-01-31C16284748780-19d75b9d0-ff91-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use stavudine safely and effectively. See full prescribing information for stavudine capsules. Stavudine Capsules, USP Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0852-1Stavudine30 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
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHSTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357STAVUDINE 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
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TSTAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3STAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SHELLACINACTIVE INGREDIENT46N107B71OSTAVUDINE 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
53808-0852STAVUDINE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20140415_7501de1e-149d-405e-94f6-da4010952adf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313108stavudine 20 MG Oral CapsulePSN7501de1e-149d-405e-94f6-da4010952adf1
313108stavudine 20 MG Oral CapsuleSCD7501de1e-149d-405e-94f6-da4010952adf1
313108D4T 20 MG Oral CapsuleSY7501de1e-149d-405e-94f6-da4010952adf1
313108DHT 20 MG Oral CapsuleSY7501de1e-149d-405e-94f6-da4010952adf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0852-15380808520130 in 1 BLISTER PACKHistorical