ritonavir

Generic: ritonavir

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ritonavir
Generic Name ritonavir
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ritonavir 100 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-061
Product ID 65162-061_6afba378-b2d9-4ae4-b5b3-cc8811f551d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208890
Listing Expiration 2026-12-31
Marketing Start 2018-09-21

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 65162061
Hyphenated Format 65162-061

Supplemental Identifiers

RxCUI
900575
UPC
0365162061062
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 (source: ndc)
Generic Name ritonavir (source: ndc)
Application Number ANDA208890 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (65162-061-06)
  • 360 TABLET in 1 BOTTLE (65162-061-32)
source: ndc

Packages (2)

65162-061-06 60 TABLET in 1 BOTTLE (65162-061-06) 65162-061-32 360 TABLET in 1 BOTTLE (65162-061-32)

Ingredients (1)

ritonavir (100 mg/1)

Linked Drug Pages (1)

Ritonavir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6afba378-b2d9-4ae4-b5b3-cc8811f551d1", "openfda": {"nui": ["N0000000246", "N0000191001", "N0000175889", "N0000190114", "N0000182137", "N0000185607", "N0000190118", "N0000185503", "N0000190113", "N0000182141", "N0000191266", "N0000185507", "N0000187064", "N0000190117"], "upc": ["0365162061062"], "unii": ["O3J8G9O825"], "rxcui": ["900575"], "spl_set_id": ["a32cb2e3-d4e5-4bbf-9d88-20b2b249e779"], "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": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (65162-061-06)", "package_ndc": "65162-061-06", "marketing_start_date": "20180921"}, {"sample": false, "description": "360 TABLET in 1 BOTTLE (65162-061-32)", "package_ndc": "65162-061-32", "marketing_start_date": "20180921"}], "brand_name": "Ritonavir", "product_id": "65162-061_6afba378-b2d9-4ae4-b5b3-cc8811f551d1", "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": "65162-061", "generic_name": "Ritonavir", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ritonavir", "active_ingredients": [{"name": "RITONAVIR", "strength": "100 mg/1"}], "application_number": "ANDA208890", "marketing_category": "ANDA", "marketing_start_date": "20180921", "listing_expiration_date": "20261231"}