stavudine

Product NDC
53104-0111
11-digit product format
531040111
Labeler code
53104
Product ID
53104-0111_526581aa-de87-4f2b-8108-85edde0b2d37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
stavudine
Dosage form
FOR SOLUTION
Route
ORAL
Labeler
Cipla Ltd.
Application
ANDA078030
Marketing category
ANDA
Marketing start
2009-03-20
Marketing end
0000-00-00
Substance
STAVUDINE
Active strength
1 mg/mL
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53104-0111-52025-12-23C16284748780-11030e365-4691-111a-e063-dadaa90a10e217e597bc-d663-4d8e-a5d3-39816b628996
53104-0111-52024-01-30C16284748780-11030e365-4691-111a-e063-dadaa90a10e217e597bc-d663-4d8e-a5d3-39816b628996

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STAVUDINEACTIVE INGREDIENTBO9LE4QFZFSTAVUDINE FOR SOLUTION [CIPLA LIMITED]4
STAVUDINEACTIVE MOIETYBO9LE4QFZFSTAVUDINE FOR SOLUTION [CIPLA LIMITED]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311STAVUDINE FOR SOLUTION [CIPLA LIMITED]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ASTAVUDINE FOR SOLUTION [CIPLA LIMITED]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSTAVUDINE FOR SOLUTION [CIPLA LIMITED]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSTAVUDINE FOR SOLUTION [CIPLA LIMITED]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSTAVUDINE FOR SOLUTION [CIPLA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53104-0111STAVUDINE FOR SOLUTION [CIPLA LTD.]8Legacy NDC20190118_17e597bc-d663-4d8e-a5d3-39816b628996.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53104-0111-553104011105200 mL in 1 BOTTLE (53104-0111-5) 200 ml2009-03-200000-00-00NoNoCurrent