Home NDC 0597-0002 Aptivus
Product NDC 0597-0002
11-digit product format 005970002
Labeler code 0597
Product ID 0597-0002_3d3e31e9-8b19-4d95-ac47-fe42aee61cde
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tipranavir
Dosage form SOLUTION
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application NDA022292
Marketing category NDA
Marketing start 2008-09-01
Marketing end 0000-00-00
Substance TIPRANAVIR
Active strength 100 mg/mL
Pharmacologic classes HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022292-001 APTIVUS TIPRANAVIR 100MG/ML SOLUTION / ORAL RLD 2008-06-23
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N022292-001 APTIVUS 100MG/ML SOLUTION / ORAL RLD 2008-06-23 a50c72e98297…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0597-0002-01 00597000201 1 BOTTLE, GLASS in 1 CARTON (0597-0002-01) > 95 mL in 1 BOTTLE, GLASS 2008-09-08 0000-00-00 No No Current