FDA.reportPublic FDA data

Ritonavir

Product NDC
31722-597
11-digit product format
317220597
Labeler code
31722
Product ID
31722-597_f5490379-7440-5901-e053-2a95a90ac1f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ritonavir
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204587
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
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
31722-597-12Ritonavir120 in 1 BOTTLETABLET1202
31722-597-30Ritonavir30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-597-30EA - Each31722-597d4ff665a-53c3-4f8d-a071-3ae2f377732e12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-597RITONAVIR (RITONAVIR) TABLET [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20230223_db633374-6d8e-4622-9fe1-f9d68baa59bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
900575ritonavir 100 MG Oral TabletPSNdb633374-6d8e-4622-9fe1-f9d68baa59bb2
900575ritonavir 100 MG Oral TabletSCDdb633374-6d8e-4622-9fe1-f9d68baa59bb2
900575ritonavir 100 MG Oral TabletPSN3c811e3e-f685-4af7-a4d1-037f2613ee681
900575ritonavir 100 MG Oral TabletSCD3c811e3e-f685-4af7-a4d1-037f2613ee681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-597-1231722059712120 TABLET in 1 BOTTLE (31722-597-12) 120 tablet2018-09-170000-00-00NoNoCurrent
31722-597-303172205973030 TABLET in 1 BOTTLE (31722-597-30) 30 tablet2018-09-170000-00-00NoNoCurrent