FDA.reportPublic FDA data

Nevirapine

Product NDC
0378-4890
11-digit product format
003784890
Labeler code
0378
Product ID
0378-4890_750bda83-d972-44e2-85ae-26676e1e7c34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nevirapine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA205651
Marketing category
ANDA
Marketing start
2014-10-29
Substance
NEVIRAPINE
Active strength
400 mg/1
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
NEVIRAPINE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii99DK7FVK1H
Rxcui1095712

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
0378-4890-93Nevirapine30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4890-93EA - Each0378-48902aa100c1-c64f-4367-8562-043a7467a0eb12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEVIRAPINEACTIVE INGREDIENT99DK7FVK1HNEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]1
NEVIRAPINEACTIVE MOIETY99DK7FVK1HNEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UINEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4890NEVIRAPINE TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 1 package rows20250116_690da74b-2481-47fc-93ae-8340e0caf0a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1095712nevirapine 400 MG 24HR Extended Release Oral TabletPSN690da74b-2481-47fc-93ae-8340e0caf0a410
109571224 HR nevirapine 400 MG Extended Release Oral TabletSCD690da74b-2481-47fc-93ae-8340e0caf0a410
1095712nevirapine 400 MG 24 HR Extended Release Oral TabletSY690da74b-2481-47fc-93ae-8340e0caf0a410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4890-930037848909330 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4890-93) 2014-10-290000-00-00NoNoCurrent