Home NDC 0056-0510 SUSTIVA
Product NDC 0056-0510
11-digit product format 000560510
Labeler code 0056
Product ID 0056-0510_41a64d5a-31b4-47ba-b508-83ad0aa316f0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name efavirenz
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bristol-Myers Squibb Pharma Company
Application NDA021360
Marketing category NDA
Marketing start 2002-02-01
Marketing end 2023-03-31
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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0056-0510-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0056-0510-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0056-0510-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0056-0510-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0056-0510-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0056-0510-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0056-0510-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0056-0510-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0056-0510-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0056-0510-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0056-0510-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0056-0510-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N021360-001 SUSTIVA EFAVIRENZ 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 N021360-002 SUSTIVA EFAVIRENZ 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01
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 · 84 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 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021360-002 SUSTIVA 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021360-002 SUSTIVA 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021360-002 SUSTIVA 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021360-002 SUSTIVA 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021360-002 SUSTIVA 600MG TABLET / ORAL RLD 2002-02-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021360-002 SUSTIVA 600MG TABLET / ORAL AB RLD, RS 2002-02-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021360-002 SUSTIVA 600MG TABLET / ORAL AB RLD, RS 2002-02-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021360-002 SUSTIVA 600MG TABLET / ORAL AB RLD, RS 2002-02-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 2002-02-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021360-002 SUSTIVA 600MG TABLET / ORAL AB RLD, RS 2002-02-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021360-001 SUSTIVA 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2002-02-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021360-002 SUSTIVA 600MG TABLET / ORAL AB RLD, RS 2002-02-01 bb7c543d1eb4…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded efavirenz ACTIVE INGREDIENT JE6H2O27P8 SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 efavirenz ACTIVE MOIETY JE6H2O27P8 SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 gelatin INACTIVE INGREDIENT 2G86QN327L SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) CAPSULE, GELATIN COATED SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [BRISTOL-MYERS SQUIBB PHARMA COMPANY] 24 efavirenz ACTIVE INGREDIENT JE6H2O27P8 SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 efavirenz ACTIVE MOIETY JE6H2O27P8 SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J SUSTIVA (EFAVIRENZ) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0056-0510-30 00056051030 30 TABLET, FILM COATED in 1 BOTTLE (0056-0510-30) 2002-01-02 0000-00-00 No No Current