FDA.reportPublic FDA data

Darunavir

Product NDC
43598-705
11-digit product format
435980705
Labeler code
43598
Product ID
43598-705_82f022df-8075-b1cd-f33b-a5603365dcc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Darunavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA211578
Marketing category
ANDA
Marketing start
2023-11-29
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
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-705-05Darunavir500 in 1 BOTTLETABLET, FILM COATED5007
43598-705-30Darunavir30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-705-30EA - Each43598-70589216710-ea34-477b-8b6b-5441e1a8798212023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-705DARUNAVIR TABLET, FILM COATED [DR.REDDYS LABORATORIES INC]7Current NDC, 2 package rows20231201_f5c9cb01-6530-4db0-a326-22a499d1efdf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
670026darunavir 600 MG Oral TabletPSNf5c9cb01-6530-4db0-a326-22a499d1efdf7
1359269darunavir 800 MG Oral TabletPSNf5c9cb01-6530-4db0-a326-22a499d1efdf7
670026darunavir 600 MG Oral TabletSCDf5c9cb01-6530-4db0-a326-22a499d1efdf7
1359269darunavir 800 MG Oral TabletSCDf5c9cb01-6530-4db0-a326-22a499d1efdf7
670026darunavir (as darunavir ethanolate) 600 MG Oral TabletSYf5c9cb01-6530-4db0-a326-22a499d1efdf7
1359269darunavir (as darunavir ethanolate) 800 MG Oral TabletSYf5c9cb01-6530-4db0-a326-22a499d1efdf7
670026darunavir (as darunavir hydrate) 600 MG Oral TabletSYf5c9cb01-6530-4db0-a326-22a499d1efdf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-705-0543598070505500 TABLET, FILM COATED in 1 BOTTLE (43598-705-05) 2023-11-29NoNoCurrent
43598-705-304359807053030 TABLET, FILM COATED in 1 BOTTLE (43598-705-30) 2023-11-29NoNoCurrent