Ritonavir

Product NDC
69097-655
11-digit product format
690970655
Labeler code
69097
Product ID
69097-655_eeb20aab-f62a-4d80-92d1-2d6b3e2a5758
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ritonavir 100 mg
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA202573
Marketing category
ANDA
Marketing start
2022-03-23
Substance
RITONAVIR
Active strength
100 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ritonavir
Brand name suffix
film coated
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RITONAVIR100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3J8G9O825
Rxcui900575

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d2364f5-8b1e-7c9a-4518-7b359d95fa50Product name220250116
00d976a9-a12a-db3d-ac4e-27498af714cfProduct name520250115
7a5f5ac7-15c0-4d8b-bea4-b3b28cb83a8dProduct name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
c8f34825-48cd-e7db-4048-c3be840a9308Product name520230123
d1ee4fdb-1116-417b-8889-dc05571445b3Product name120160825
f8d26468-b1dc-49d8-a188-8b5d531405efProduct name120150731
0b1bb9d1-e628-4e7c-aada-fd6532257932Product name120150416
96979b26-bb9a-43d8-e3a6-d69b9e9f75e5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-655-02Ritonavirfilm coated30 in 1 CONTAINERTABLET302
69097-655-08Ritonavirfilm coated120 in 1 CONTAINERTABLET1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-655RITONAVIR FILM COATED (RITONAVIR 100 MG) TABLET [CIPLA USA INC.]2Current NDC, Legacy NDC, 2 package rows20230316_4633c6ba-168d-426f-acae-7843e167743a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900575ritonavir 100 MG Oral TabletPSN4633c6ba-168d-426f-acae-7843e167743a2
900575ritonavir 100 MG Oral TabletSCD4633c6ba-168d-426f-acae-7843e167743a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-655-026909706550230 TABLET in 1 CONTAINER (69097-655-02) 30 tablet2022-03-230000-00-00NoNoCurrent
69097-655-0869097065508120 TABLET in 1 CONTAINER (69097-655-08) 120 tablet2022-03-230000-00-00NoNoCurrent