Norvir

Product NDC
0074-1940
11-digit product format
000741940
Labeler code
0074
Product ID
0074-1940_ff281f75-bfea-433a-8d28-d33cdb898f00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ritonavir
Dosage form
SOLUTION
Route
ORAL
Labeler
AbbVie Inc.
Application
NDA020659
Marketing category
NDA
Marketing start
2010-05-06
Marketing end
0000-00-00
Substance
RITONAVIR
Active strength
80 mg/mL
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
2024-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0074-1940DDiscontinued by firm2026-08-17
excluded packagepackage0074-19400074-1940-63DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0074-1940-63d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0074-1940-63f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0074-1940-632ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0074-1940-63a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0074-1940-63cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0074-1940-63cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0074-1940-63302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0074-1940-63ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0074-1940-630efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0074-1940-63ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0074-1940-63367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0074-1940-63557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020659-001NORVIRRITONAVIR80MG/MLSOLUTION / ORALRLD1996-03-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-0187673890dc5c…
2021-03-12 10:30 UTC2021-03N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-013f01610625f2…
2019-09-15 20:21 UTC2019-09N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-01b00525d2431f…
2019-07-19 19:46 UTC2019-07N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-013f0d92c62455…
2023-05-13 08:27 UTC2023-05N020659-001NORVIR80MG/MLSOLUTION / ORALRLD1996-03-01053a50430f4f…
2023-01-26 05:58 UTC2023-01N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020659-001NORVIR80MG/MLSOLUTION / ORALRLD, RS1996-03-01e64feba35796…

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f34825-48cd-e7db-4048-c3be840a9308Product name520230123
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d1ee4fdb-1116-417b-8889-dc05571445b3Product name120160825
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-1940-63Norvir1 in 1 CARTONSOLUTION11651
0074-1940-63Norvir240 mL in 1 BOTTLESOLUTION2401651

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-1940-63ML - Milliliter0074-1940b736767a-6124-43bb-ac9d-86c75c570bd612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RITONAVIRACTIVE INGREDIENTO3J8G9O825NORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
RITONAVIRACTIVE MOIETYO3J8G9O825NORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
ALCOHOLINACTIVE INGREDIENT3K9958V90MNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
CARAMELINACTIVE INGREDIENTT9D99G2B1RNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6ONORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UINORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
TALCINACTIVE INGREDIENT7SEV7J4R1UNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509
WATERINACTIVE INGREDIENT059QF0KO0RNORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION [ABBVIE INC.]1509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-1940NORVIR (RITONAVIR) TABLET, FILM COATED NORVIR (RITONAVIR) SOLUTION NORVIR (RITONAVIR) POWDER [ABBVIE INC.]1649Legacy NDC, 2 package rows20250223_2849298e-de6e-47bb-8194-56e075b33fc3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NorvirRITONAVIRAbbVie Inc.2849298e-de6e-47bb-8194-56e075b33fc32026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 0074-1940

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1926069Norvir 100 MG Oral PowderPSN2849298e-de6e-47bb-8194-56e075b33fc31651
900577Norvir 100 MG Oral TabletPSN2849298e-de6e-47bb-8194-56e075b33fc31651
152971Norvir 80 MG in 1 mL Oral SolutionPSN2849298e-de6e-47bb-8194-56e075b33fc31651
1926066ritonavir 100 MG Oral PowderPSN2849298e-de6e-47bb-8194-56e075b33fc31651
900575ritonavir 100 MG Oral TabletPSN2849298e-de6e-47bb-8194-56e075b33fc31651
199249ritonavir 80 MG in 1 mL Oral SolutionPSN2849298e-de6e-47bb-8194-56e075b33fc31651
1926069ritonavir 100 MG Oral Powder [Norvir]SBD2849298e-de6e-47bb-8194-56e075b33fc31651
900577ritonavir 100 MG Oral Tablet [Norvir]SBD2849298e-de6e-47bb-8194-56e075b33fc31651
152971ritonavir 80 MG/ML Oral Solution [Norvir]SBD2849298e-de6e-47bb-8194-56e075b33fc31651
1926066ritonavir 100 MG Oral PowderSCD2849298e-de6e-47bb-8194-56e075b33fc31651
900575ritonavir 100 MG Oral TabletSCD2849298e-de6e-47bb-8194-56e075b33fc31651
199249ritonavir 80 MG/ML Oral SolutionSCD2849298e-de6e-47bb-8194-56e075b33fc31651
1926069Norvir 100 MG Oral PowderSY2849298e-de6e-47bb-8194-56e075b33fc31651
900577Norvir 100 MG Oral TabletSY2849298e-de6e-47bb-8194-56e075b33fc31651
152971Norvir 80 MG per 1 ML Oral SolutionSY2849298e-de6e-47bb-8194-56e075b33fc31651
152971Norvir 80 MG/ML Oral SolutionSY2849298e-de6e-47bb-8194-56e075b33fc31651
199249ritonavir 80 MG per 1 ML Oral SolutionSY2849298e-de6e-47bb-8194-56e075b33fc31651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-1940-63000741940631 BOTTLE in 1 CARTON (0074-1940-63) > 240 mL in 1 BOTTLE1 bottle2010-05-060000-00-00NoNoCurrent