FDA.reportPublic FDA data

Nevirapine

Product NDC
65862-057
11-digit product format
658620057
Labeler code
65862
Product ID
65862-057_fd37e474-7411-4466-bf46-36fc74ef6684
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nevirapine
Dosage form
SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077702
Marketing category
ANDA
Marketing start
2012-05-22
Substance
NEVIRAPINE HEMIHYDRATE
Active strength
50 mg/5mL
Pharmacologic classes
Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nevirapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEVIRAPINE HEMIHYDRATE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB7XF2TD73C
Rxcui311943

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1bab0e5-3c0a-775a-2f29-a19e4e281871Product name320190610
d07e0b9e-e041-41dc-942a-a2a6601dc221Product name120181029
0d48f664-b8cd-5c4b-aa8e-0a00f1c0002dProduct name820171204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-057-11Nevirapine100 mL in 1 BOTTLESUSPENSION10012
65862-057-24Nevirapine240 mL in 1 BOTTLESUSPENSION24012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-057-24ML - Milliliter65862-057de883c2d-932f-425a-8be1-ba946370a0f312018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEVIRAPINE HEMIHYDRATEACTIVE INGREDIENTB7XF2TD73CNEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4
NEVIRAPINEACTIVE MOIETY99DK7FVK1HNEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTF68VH75CJCNEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4
SORBITOLINACTIVE INGREDIENT506T60A25RNEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4
SUCROSEINACTIVE INGREDIENTC151H8M554NEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4
WATERINACTIVE INGREDIENT059QF0KO0RNEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-057NEVIRAPINE SUSPENSION [AUROBINDO PHARMA LIMITED]12Current NDC, Legacy NDC, 2 package rows20240921_8dfe86aa-ea5d-48d2-94a8-1a5506055d70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311943nevirapine 50 MG in 5 mL Oral SuspensionPSN8dfe86aa-ea5d-48d2-94a8-1a5506055d7012
311943nevirapine 10 MG/ML Oral SuspensionSCD8dfe86aa-ea5d-48d2-94a8-1a5506055d7012
311943nevirapine (as nevirapine hemihydrate) 10 MG/ML Oral SuspensionSY8dfe86aa-ea5d-48d2-94a8-1a5506055d7012
311943nevirapine 50 MG per 5 ML Oral SuspensionSY8dfe86aa-ea5d-48d2-94a8-1a5506055d7012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-057-1165862005711100 mL in 1 BOTTLE (65862-057-11) 100 ml2012-05-220000-00-00NoNoCurrent
65862-057-2465862005724240 mL in 1 BOTTLE (65862-057-24) 240 ml2012-05-220000-00-00NoNoCurrent