FDA.reportPublic FDA data

ZERIT

Product NDC
53808-0656
11-digit product format
538080656
Labeler code
53808
Product ID
53808-0656_66893c23-b206-4107-ad2b-1af596b4c5c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
stavudine
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020412
Marketing category
NDA
Marketing start
2009-07-01
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
E
Listing certified through
2017-12-31
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
53808-0656-12019-10-21C16284748780-1956f9ecf-d1ac-621f-e053-dbdaa90a74adZERIT ® (stavudine) Capsules ZERIT ® (stavudine) for Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0656-1ZERIT30 in 1 BLISTER PACKCAPSULE, GELATIN COATED303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STAVUDINEACTIVE INGREDIENTBO9LE4QFZFZERIT (STAVUDINE) CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
stavudineACTIVE MOIETYBO9LE4QFZFZERIT (STAVUDINE) CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZERIT (STAVUDINE) CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
GELATININACTIVE INGREDIENT2G86QN327LZERIT (STAVUDINE) CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GZERIT (STAVUDINE) CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZERIT (STAVUDINE) CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ZERIT (STAVUDINE) CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZERIT (STAVUDINE) CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0656ZERIT (STAVUDINE) CAPSULE, GELATIN COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]3Legacy NDC, 1 package rows20100813_8bb73c56-74cb-4602-b9a3-57bd1082b434.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313108stavudine 20 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
313109stavudine 30 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
313110stavudine 40 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
152942Zerit 20 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
152943Zerit 30 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
152944Zerit 40 MG Oral CapsulePSN8bb73c56-74cb-4602-b9a3-57bd1082b4343
152942stavudine 20 MG Oral Capsule [Zerit]SBD8bb73c56-74cb-4602-b9a3-57bd1082b4343
152943stavudine 30 MG Oral Capsule [Zerit]SBD8bb73c56-74cb-4602-b9a3-57bd1082b4343
152944stavudine 40 MG Oral Capsule [Zerit]SBD8bb73c56-74cb-4602-b9a3-57bd1082b4343
313108stavudine 20 MG Oral CapsuleSCD8bb73c56-74cb-4602-b9a3-57bd1082b4343
313109stavudine 30 MG Oral CapsuleSCD8bb73c56-74cb-4602-b9a3-57bd1082b4343
313110stavudine 40 MG Oral CapsuleSCD8bb73c56-74cb-4602-b9a3-57bd1082b4343
313108D4T 20 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152942D4T 20 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
313109D4T 30 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152943D4T 30 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
313110D4T 40 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152944D4T 40 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
313108DHT 20 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152942DHT 20 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
313109DHT 30 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152943DHT 30 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
313110DHT 40 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152944DHT 40 MG Oral Capsule [Zerit]SY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152942Zerit 20 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152943Zerit 30 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343
152944Zerit 40 MG Oral CapsuleSY8bb73c56-74cb-4602-b9a3-57bd1082b4343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0656-15380806560130 in 1 BLISTER PACKHistorical