Ritonavir

Product NDC
65862-687
11-digit product format
658620687
Labeler code
65862
Product ID
65862-687_dca8eddf-c54f-4b6e-b56c-19d6dd3e7e90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ritonavir
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206614
Marketing category
ANDA
Marketing start
2018-09-17
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c8f34825-48cd-e7db-4048-c3be840a9308Product name520230123
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d1ee4fdb-1116-417b-8889-dc05571445b3Product name120160825
f8d26468-b1dc-49d8-a188-8b5d531405efProduct name120150731
0b1bb9d1-e628-4e7c-aada-fd6532257932Product name120150416
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96979b26-bb9a-43d8-e3a6-d69b9e9f75e5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-687-01Ritonavir100 in 1 BOTTLETABLET, FILM COATED1008
65862-687-05Ritonavir500 in 1 BOTTLETABLET, FILM COATED5008
65862-687-30Ritonavir30 in 1 BOTTLETABLET, FILM COATED308
65862-687-99Ritonavir1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-687-30EA - Each65862-68755bff334-ec1f-4b36-ae61-25f25a3ed6f612018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-687RITONAVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 4 package rows20231114_11f757f1-cf48-47a8-925e-918359cbd2d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900575ritonavir 100 MG Oral TabletPSNd2f8c6ba-5e06-4b03-8ca5-b4fd7e5a8925100
900575ritonavir 100 MG Oral TabletSCDd2f8c6ba-5e06-4b03-8ca5-b4fd7e5a8925100
900575ritonavir 100 MG Oral TabletPSN11f757f1-cf48-47a8-925e-918359cbd2d48
900575ritonavir 100 MG Oral TabletSCD11f757f1-cf48-47a8-925e-918359cbd2d48
900575ritonavir 100 MG Oral TabletPSN19503bc4-3443-4ad4-aa27-437f4f3288b15
900575ritonavir 100 MG Oral TabletSCD19503bc4-3443-4ad4-aa27-437f4f3288b15
900575ritonavir 100 MG Oral TabletPSN26a5440b-8611-c104-e063-6294a90af1fc1
900575ritonavir 100 MG Oral TabletPSN3f92f1e2-59f4-f6c4-e063-6294a90a487b1
900575ritonavir 100 MG Oral TabletSCD26a5440b-8611-c104-e063-6294a90af1fc1
900575ritonavir 100 MG Oral TabletSCD3f92f1e2-59f4-f6c4-e063-6294a90a487b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-687-0165862068701100 TABLET, FILM COATED in 1 BOTTLE (65862-687-01) 2018-09-170000-00-00NoNoCurrent
65862-687-0565862068705500 TABLET, FILM COATED in 1 BOTTLE (65862-687-05) 2018-09-170000-00-00NoNoCurrent
65862-687-306586206873030 TABLET, FILM COATED in 1 BOTTLE (65862-687-30) 2018-09-170000-00-00NoNoCurrent
65862-687-99658620687991000 TABLET, FILM COATED in 1 BOTTLE (65862-687-99) 2018-09-170000-00-00NoNoCurrent