FDA.reportPublic FDA data

Darunavir

Product NDC
72578-148
11-digit product format
725780148
Labeler code
72578
Product ID
72578-148_de3be678-a82f-4052-b7ce-728d887d548e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Darunavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA214085
Marketing category
ANDA
Marketing start
2024-05-01
Substance
DARUNAVIR
Active strength
800 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DARUNAVIR800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYO603Y8113
Rxcui670026, 1359269

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
81157882-d7f5-4b49-9a52-b2a0c7e54020Product name220260107
12fd8c59-0b3a-2882-9cdb-92782ec03e2fProduct name620251113
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-148-05Darunavir500 in 1 BOTTLETABLET, FILM COATED5001
72578-148-06Darunavir30 in 1 BOTTLETABLET, FILM COATED301
72578-148-16Darunavir90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-148-06EA - Each72578-148902a762b-ea27-41d6-86b7-c6dfca84e6a012024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-148DARUNAVIR TABLET, FILM COATED [VIONA PHARMACEUTICALS INC]1Current NDC, 3 package rows20240501_04a542b3-15ad-4a8a-aab4-ace8e08732f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
670026darunavir 600 MG Oral TabletPSN04a542b3-15ad-4a8a-aab4-ace8e08732f31
1359269darunavir 800 MG Oral TabletPSN04a542b3-15ad-4a8a-aab4-ace8e08732f31
670026darunavir 600 MG Oral TabletSCD04a542b3-15ad-4a8a-aab4-ace8e08732f31
1359269darunavir 800 MG Oral TabletSCD04a542b3-15ad-4a8a-aab4-ace8e08732f31
670026darunavir (as darunavir ethanolate) 600 MG Oral TabletSY04a542b3-15ad-4a8a-aab4-ace8e08732f31
1359269darunavir (as darunavir ethanolate) 800 MG Oral TabletSY04a542b3-15ad-4a8a-aab4-ace8e08732f31
670026darunavir (as darunavir hydrate) 600 MG Oral TabletSY04a542b3-15ad-4a8a-aab4-ace8e08732f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72578-148-0572578014805500 TABLET, FILM COATED in 1 BOTTLE (72578-148-05) 2024-05-01NoNoHistorical
72578-148-067257801480630 TABLET, FILM COATED in 1 BOTTLE (72578-148-06) 2024-05-01NoNoHistorical
72578-148-167257801481690 TABLET, FILM COATED in 1 BOTTLE (72578-148-16) 2024-05-01NoNoHistorical