Home NDC 80005-112 ETRAVIRINE
Product NDC 80005-112
11-digit product format 800050112
Labeler code 80005
Product ID 80005-112_4b21f36b-78b4-41db-ae59-814076cf5b90
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ETRAVIRINE
Dosage form TABLET
Route ORAL
Labeler Carnegie Pharmaceuticals LLC
Application ANDA215402
Marketing category ANDA
Marketing start 2022-06-07
Substance ETRAVIRINE
Active strength 100 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 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215402-001 ETRAVIRINE ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 A215402-002 ETRAVIRINE ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13
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 2 · 58 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 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215402-001 ETRAVIRINE 100MG TABLET / ORAL AB 2022-04-13 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215402-002 ETRAVIRINE 200MG TABLET / ORAL AB 2022-04-13 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ETRAVIRINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETRAVIRINE 100 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80005-112-12 ETRAVIRINE 120 in 1 BOTTLE TABLET 120 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80005-112 ETRAVIRINE TABLET [CARNEGIE PHARMACEUTICALS LLC] 6 Current NDC, Legacy NDC, 1 package rows 20240307_154b621d-9a72-489f-9127-55f9bf1797a0.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 80005-112-12 80005011212 120 TABLET in 1 BOTTLE (80005-112-12) 120 tablet 2022-06-07 0000-00-00 No No Current