ritonavir film coated

Generic: ritonavir 100 mg

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ritonavir film coated
Generic Name ritonavir 100 mg
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ritonavir 100 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-655
Product ID 69097-655_eeb20aab-f62a-4d80-92d1-2d6b3e2a5758
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202573
Listing Expiration 2026-12-31
Marketing Start 2022-03-23

Pharmacologic Class

Established (EPC)
cytochrome p450 3a inhibitor [epc] protease inhibitor [epc]
Mechanism of Action
hiv protease inhibitors [moa] cytochrome p450 3a inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 2c19 inducers [moa] cytochrome p450 3a inducers [moa] p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 1a2 inducers [moa] cytochrome p450 2c9 inducers [moa] cytochrome p450 2b6 inducers [moa] udp glucuronosyltransferases inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097655
Hyphenated Format 69097-655

Supplemental Identifiers

RxCUI
900575
UPC
0369097655082 0369097655020
UNII
O3J8G9O825
NUI
N0000000246 N0000191001 N0000175889 N0000190114 N0000182137 N0000185607 N0000190118 N0000185503 N0000190113 N0000182141 N0000191266 N0000185507 N0000187064 N0000190117

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ritonavir film coated (source: ndc)
Generic Name ritonavir 100 mg (source: ndc)
Application Number ANDA202573 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 CONTAINER (69097-655-02)
  • 120 TABLET in 1 CONTAINER (69097-655-08)
source: ndc

Packages (2)

Ingredients (1)

ritonavir (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "eeb20aab-f62a-4d80-92d1-2d6b3e2a5758", "openfda": {"nui": ["N0000000246", "N0000191001", "N0000175889", "N0000190114", "N0000182137", "N0000185607", "N0000190118", "N0000185503", "N0000190113", "N0000182141", "N0000191266", "N0000185507", "N0000187064", "N0000190117"], "upc": ["0369097655082", "0369097655020"], "unii": ["O3J8G9O825"], "rxcui": ["900575"], "spl_set_id": ["4633c6ba-168d-426f-acae-7843e167743a"], "pharm_class_epc": ["Cytochrome P450 3A Inhibitor [EPC]", "Protease Inhibitor [EPC]"], "pharm_class_moa": ["HIV Protease Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "UDP Glucuronosyltransferases Inducers [MoA]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 CONTAINER (69097-655-02)", "package_ndc": "69097-655-02", "marketing_start_date": "20220323"}, {"sample": false, "description": "120 TABLET in 1 CONTAINER (69097-655-08)", "package_ndc": "69097-655-08", "marketing_start_date": "20220323"}], "brand_name": "Ritonavir film coated", "product_id": "69097-655_eeb20aab-f62a-4d80-92d1-2d6b3e2a5758", "dosage_form": "TABLET", "pharm_class": ["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]"], "product_ndc": "69097-655", "generic_name": "ritonavir 100 mg", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ritonavir", "brand_name_suffix": "film coated", "active_ingredients": [{"name": "RITONAVIR", "strength": "100 mg/1"}], "application_number": "ANDA202573", "marketing_category": "ANDA", "marketing_start_date": "20220323", "listing_expiration_date": "20261231"}