Home NDC 33342-599-54 Rifapentine
Product NDC 33342-599
Requested package NDC 33342-599-54
11-digit product format 333420599
Labeler code 33342
Product ID 33342-599_f95d726e-5a09-48dd-b719-e4400fb91c8f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rifapentine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA217042
Marketing category ANDA
Marketing start 2026-06-23
Substance RIFAPENTINE
Active strength 150 mg/1
Pharmacologic classes Rifamycin Antimycobacterial [EPC]; Rifamycins [CS]
Listing certified through 2027-12-31
Current FDA listing Yes 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 A217042-001 RIFAPENTINE RIFAPENTINE 150MG TABLET / ORAL AB 2026-06-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217042-001 AB
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217042-001 RIFAPENTINE 150MG TABLET / ORAL AB 2026-06-23 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217042-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Rifapentine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIFAPENTINE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XJM390A33U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242671 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 33342-599-54 33342059954 3 BLISTER PACK in 1 CARTON (33342-599-54) / 8 TABLET, FILM COATED in 1 BLISTER PACK (33342-599-20) 3 blister pack 2026-06-23 0 Current