FDA.reportPublic FDA data

Darunavir

Product NDC
60687-808
11-digit product format
606870808
Labeler code
60687
Product ID
60687-808_1a392399-f30c-b533-e063-6294a90a1e67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Darunavir
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA206288
Marketing category
ANDA
Marketing start
2024-06-09
Substance
DARUNAVIR DIHYDRATE
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
DARUNAVIR DIHYDRATE600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKPC4NRB25L
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
60687-808-11Darunavir1 in 1 BLISTER PACKTABLET12
60687-808-21Darunavir30 in 1 CARTONTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-808-11EA - Each60687-808c8a67acb-7e4f-485d-8aa4-2b7e5a927acd12024-06-10
60687-808-21EA - Each60687-808b505240b-4ac0-4b73-af50-172d4625961812024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-808DARUNAVIR TABLET [AMERICAN HEALTH PACKAGING]2Current NDC, 2 package rows20240609_632293b0-d220-444e-8a5b-2ee8c225b66d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
670026darunavir 600 MG Oral TabletPSN632293b0-d220-444e-8a5b-2ee8c225b66d2
1359269darunavir 800 MG Oral TabletPSN632293b0-d220-444e-8a5b-2ee8c225b66d2
670026darunavir 600 MG Oral TabletSCD632293b0-d220-444e-8a5b-2ee8c225b66d2
1359269darunavir 800 MG Oral TabletSCD632293b0-d220-444e-8a5b-2ee8c225b66d2
670026darunavir (as darunavir ethanolate) 600 MG Oral TabletSY632293b0-d220-444e-8a5b-2ee8c225b66d2
1359269darunavir (as darunavir ethanolate) 800 MG Oral TabletSY632293b0-d220-444e-8a5b-2ee8c225b66d2
670026darunavir (as darunavir hydrate) 600 MG Oral TabletSY632293b0-d220-444e-8a5b-2ee8c225b66d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-808-11606870808111 in 1 BLISTER PACKHistorical
60687-808-216068708082130 BLISTER PACK in 1 CARTON (60687-808-21) / 1 TABLET in 1 BLISTER PACK (60687-808-11) 30 blister pack2024-06-09NoNoCurrent