FDA.reportPublic FDA data

Darunavir

Product NDC
60219-1144
11-digit product format
602191144
Labeler code
60219
Product ID
60219-1144_7fb8acac-13ca-47ca-8b06-d12900d4943b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Darunavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA212493
Marketing category
ANDA
Marketing start
2023-12-09
Substance
DARUNAVIR
Active strength
600 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
DARUNAVIR600 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1144-6Darunavir60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
60219-1144-6Darunavir1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1144-6EA - Each60219-11444cfab6e3-a449-47cc-a9aa-5a450d53e8bb12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1144DARUNAVIR TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]4Current NDC, 2 package rows20250319_92b286d5-1ee5-435b-9e1d-2e95c7f2ec69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
670026darunavir 600 MG Oral TabletPSN92b286d5-1ee5-435b-9e1d-2e95c7f2ec694
1359269darunavir 800 MG Oral TabletPSN92b286d5-1ee5-435b-9e1d-2e95c7f2ec694
670026darunavir 600 MG Oral TabletSCD92b286d5-1ee5-435b-9e1d-2e95c7f2ec694
1359269darunavir 800 MG Oral TabletSCD92b286d5-1ee5-435b-9e1d-2e95c7f2ec694
670026darunavir (as darunavir ethanolate) 600 MG Oral TabletSY92b286d5-1ee5-435b-9e1d-2e95c7f2ec694
1359269darunavir (as darunavir ethanolate) 800 MG Oral TabletSY92b286d5-1ee5-435b-9e1d-2e95c7f2ec694
670026darunavir (as darunavir hydrate) 600 MG Oral TabletSY92b286d5-1ee5-435b-9e1d-2e95c7f2ec694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60219-1144-6602191144061 BOTTLE, PLASTIC in 1 CARTON (60219-1144-6) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2023-12-09NoNoHistorical