Home NDC 65862-049-15 Efavirenz
Product NDC 65862-049
Requested package NDC 65862-049-15
11-digit product format 658620049
Labeler code 65862
Product ID 65862-049_f9982eb1-1e15-4fad-99f9-0f9da04fd058
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Efavirenz
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA077673
Marketing category ANDA
Marketing start 2018-09-21
Substance EFAVIRENZ
Active strength 600 mg/1
Pharmacologic classes Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A077673-001 EFAVIRENZ EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077673-001 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.
Product history page 1 of 2 · 42 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 2026-08-18 06:07:40 2026-07 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077673-001 EFAVIRENZ 600MG TABLET / ORAL 2018-09-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077673-001 EFAVIRENZ 600MG TABLET / ORAL 2018-09-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077673-001 EFAVIRENZ 600MG TABLET / ORAL 2018-09-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077673-001 EFAVIRENZ 600MG TABLET / ORAL 2018-09-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077673-001 EFAVIRENZ 600MG TABLET / ORAL AB 2018-09-21 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Efavirenz
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EFAVIRENZ 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JE6H2O27P8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349477 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 65862-049-10 Efavirenz 3 in 1 CARTON TABLET, FILM COATED 3 10 65862-049-10 Efavirenz 10 in 1 BLISTER PACK TABLET, FILM COATED 10 10 65862-049-30 Efavirenz 30 in 1 BOTTLE TABLET, FILM COATED 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-049 EFAVIRENZ TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 10 Current NDC, Legacy NDC, 3 package rows 20240104_c5eedb5d-4cab-4056-a14a-ffdf67701355.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Status 65862-049-15 65862004915 1500 TABLET, FILM COATED in 1 BAG (65862-049-15) 21-SEP-18 Current