FDA.reportPublic FDA data

Aptivus

Product NDC
0597-0003
Requested package NDC
0597-0003-02
11-digit product format
005970003
Labeler code
0597
Product ID
0597-0003_089edede-222a-4895-ac85-82b775ef3352
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tipranavir
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA021814
Marketing category
NDA
Marketing start
2005-07-01
Substance
TIPRANAVIR
Active strength
250 mg/1
Pharmacologic classes
HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0597-00030597-0003-02IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021814-001APTIVUSTIPRANAVIR250MGCAPSULE / ORALRLD, RS2005-06-22

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021814-001APTIVUS250MGCAPSULE / ORALRLD, RS2005-06-22a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d546ba7f-d76b-ca37-803f-01860333d2f5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0003-02Aptivus120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED12019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0003-02EA - Each0597-000320dae680-091a-4f62-b9bc-f15e3a6f0c5f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tipranavirACTIVE INGREDIENTZZT404XD09APTIVUS (TIPRANAVIR) CAPSULE, LIQUID FILLED APTIVUS (TIPRANAVIR) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]9
tipranavirACTIVE MOIETYZZT404XD09APTIVUS (TIPRANAVIR) CAPSULE, LIQUID FILLED APTIVUS (TIPRANAVIR) SOLUTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0003APTIVUS (TIPRANAVIR) CAPSULE, LIQUID FILLED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 1 package rows20240524_08982e49-d2eb-4b25-b01a-1be52fd669ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
603378Aptivus 250 MG Oral CapsulePSN08982e49-d2eb-4b25-b01a-1be52fd669ef19
577212tipranavir 250 MG Oral CapsulePSN08982e49-d2eb-4b25-b01a-1be52fd669ef19
603378tipranavir 250 MG Oral Capsule [Aptivus]SBD08982e49-d2eb-4b25-b01a-1be52fd669ef19
577212tipranavir 250 MG Oral CapsuleSCD08982e49-d2eb-4b25-b01a-1be52fd669ef19
603378Aptivus 250 MG Oral CapsuleSY08982e49-d2eb-4b25-b01a-1be52fd669ef19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0597-0003-0200597000302120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0597-0003-02) 2005-07-010000-00-00NoNoCurrent