FDA.reportPublic FDA data

Darunavir 600 and 800 mg

Product NDC
69097-244
11-digit product format
690970244
Labeler code
69097
Product ID
69097-244_e3d4803e-30b2-4c8b-90e3-b04c2da4b1c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
darunavir
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA206288
Marketing category
ANDA
Marketing start
2023-11-29
Substance
DARUNAVIR HYDRATE
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 600 and 800 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DARUNAVIR HYDRATE800 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
69097-244-02Darunavir 600 and 800 mg30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-244DARUNAVIR 600 AND 800 MG (DARUNAVIR) TABLET [CIPLA USA INC.]3Current NDC, 1 package rows20240120_5624cc30-d484-458e-b234-9bb745a118ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
670026darunavir 600 MG Oral TabletPSN5624cc30-d484-458e-b234-9bb745a118ca3
1359269darunavir 800 MG Oral TabletPSN5624cc30-d484-458e-b234-9bb745a118ca3
670026darunavir 600 MG Oral TabletSCD5624cc30-d484-458e-b234-9bb745a118ca3
1359269darunavir 800 MG Oral TabletSCD5624cc30-d484-458e-b234-9bb745a118ca3
670026darunavir (as darunavir ethanolate) 600 MG Oral TabletSY5624cc30-d484-458e-b234-9bb745a118ca3
1359269darunavir (as darunavir ethanolate) 800 MG Oral TabletSY5624cc30-d484-458e-b234-9bb745a118ca3
670026darunavir (as darunavir hydrate) 600 MG Oral TabletSY5624cc30-d484-458e-b234-9bb745a118ca3
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
1359269darunavir 800 MG Oral TabletPSNbf99d8b8-c4e0-4cb4-924e-8cdcfd8d1aa11
1359269darunavir 800 MG Oral TabletSCDbf99d8b8-c4e0-4cb4-924e-8cdcfd8d1aa11
1359269darunavir (as darunavir ethanolate) 800 MG Oral TabletSYbf99d8b8-c4e0-4cb4-924e-8cdcfd8d1aa11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-244-026909702440230 TABLET in 1 BOTTLE (69097-244-02) 30 tablet2023-11-29NoNoCurrent