Home NDC 42291-474 etravirine
Product NDC 42291-474
11-digit product format 422910474
Labeler code 42291
Product ID 42291-474_48497b19-7665-4ce1-e063-6394a90ad69b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name etravirine
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA214196
Marketing category ANDA
Marketing start 2022-10-04
Substance ETRAVIRINE
Active strength 200 mg/1
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214196-001 ETRAVIRINE ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 A214196-002 ETRAVIRINE ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 A214196-003 ETRAVIRINE ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 99 observed 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 2026-02-19 14:30 UTC 2026-02 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214196-002 ETRAVIRINE 100MG TABLET / ORAL AB 2021-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214196-003 ETRAVIRINE 200MG TABLET / ORAL AB 2021-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214196-001 ETRAVIRINE 25MG TABLET / ORAL 2021-06-14 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base etravirine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETRAVIRINE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0C50HW4FO1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 754761 Internal RxNorm lookup 1052658 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-474-60 etravirine 60 in 1 BOTTLE TABLET 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-474 ETRAVIRINE TABLET [AVKARE] 2 Current NDC, Legacy NDC, 1 package rows 20240110_ea3856f6-fedf-ee88-e053-2a95a90a33ce.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-474-60 42291047460 60 TABLET in 1 BOTTLE (42291-474-60) 60 tablet 2022-10-04 0000-00-00 No No Current