FDA.reportPublic FDA data

Norvir

Product NDC
53808-1119
11-digit product format
538081119
Labeler code
53808
Product ID
53808-1119_ba727e7e-57cc-4564-afd1-9464f34f4d7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ritonavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
NDA022417
Marketing category
NDA
Marketing start
2018-01-09
Marketing end
0000-00-00
Substance
RITONAVIR
Active strength
100 mg/1
Pharmacologic classes
HIV Protease Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],Protease Inhibitor [EPC],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]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d2364f5-8b1e-7c9a-4518-7b359d95fa50Product name220250116
00d976a9-a12a-db3d-ac4e-27498af714cfProduct name520250115
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
7a5f5ac7-15c0-4d8b-bea4-b3b28cb83a8dProduct name120231023
c8f34825-48cd-e7db-4048-c3be840a9308Product name520230123
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d1ee4fdb-1116-417b-8889-dc05571445b3Product name120160825
f8d26468-b1dc-49d8-a188-8b5d531405efProduct name120150731
0b1bb9d1-e628-4e7c-aada-fd6532257932Product name120150416
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
96979b26-bb9a-43d8-e3a6-d69b9e9f75e5Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1119-12024-01-30C16284748780-11030e365-01cd-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use NORVIR safely and effectively. See full prescribing information for NORVIR. NORVIR (ritonavir) tablets, for oral use NORVIR (ritonavir) oral solution NORVIR (ritonavir) oral powder Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1119-1Norvir30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1119NORVIR (RITONAVIR) TABLET, FILM COATED [DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20190123_bc00d131-afc3-457f-b18f-065775af6f1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900577Norvir 100 MG Oral TabletPSNbc00d131-afc3-457f-b18f-065775af6f1c2
900575ritonavir 100 MG Oral TabletPSNbc00d131-afc3-457f-b18f-065775af6f1c2
900577ritonavir 100 MG Oral Tablet [Norvir]SBDbc00d131-afc3-457f-b18f-065775af6f1c2
900575ritonavir 100 MG Oral TabletSCDbc00d131-afc3-457f-b18f-065775af6f1c2
900577Norvir 100 MG Oral TabletSYbc00d131-afc3-457f-b18f-065775af6f1c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53808-1119-15380811190130 TABLET, FILM COATED in 1 BLISTER PACK (53808-1119-1) 2018-01-090000-00-00NoNoCurrent