Home NDC 0003-3641 EVOTAZ
Product NDC 0003-3641
11-digit product format 000033641
Labeler code 0003
Product ID 0003-3641_fa642c67-5a9e-4136-a141-64e1236f6a0f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atazanavir and cobicistat
Dosage form TABLET
Route ORAL
Labeler E.R. Squibb & Sons, L.L.C.
Application NDA206353
Marketing category NDA
Marketing start 2015-01-29
Substance ATAZANAVIR SULFATE; COBICISTAT
Active strength 300; 150 mg/1; mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inhibitors [MoA], UGT1A1 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206353-001 EVOTAZ ATAZANAVIR SULFATE; COBICISTAT EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 N206353-001 10039718 2032-10-06 Drug product 2018-09-05
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 · 41 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 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206353-001 EVOTAZ EQ 300MG BASE;150MG TABLET / ORAL RLD, RS 2015-01-29 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206353-001 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206353-001 10039718 2032-10-04 Drug product 2018-09-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206353-001 10039718 2032-10-06 Drug product 2018-09-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206353-001 8148374 2029-09-03 U-1279 Drug substance, Drug product 2015-02-25 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base EVOTAZ
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATAZANAVIR SULFATE 300 mg/1 COBICISTAT 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4MT4VIE29P Internal UNII lookup LW2E03M5PG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1601654 Internal RxNorm lookup 1601660 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 0003-3641-11 EVOTAZ 30 in 1 BOTTLE TABLET 30 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATAZANAVIR SULFATE ACTIVE INGREDIENT 4MT4VIE29P EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 COBICISTAT ACTIVE INGREDIENT LW2E03M5PG EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 ATAZANAVIR ACTIVE MOIETY QZU4H47A3S EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 COBICISTAT ACTIVE MOIETY LW2E03M5PG EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0003-3641 EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET [E.R. SQUIBB & SONS, L.L.C.] 16 Current NDC, Legacy NDC, 1 package rows 20250524_83db29d7-5d85-49d6-8cb6-740473365cf8.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EVOTAZ ATAZANAVIR AND COBICISTAT E.R. Squibb & Sons, L.L.C. 83db29d7-5d85-49d6-8cb6-740473365cf8 2025-05-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 206353 application number: NDA206353 ndc (product): 0003-3641
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 0003-3641-11 00003364111 30 TABLET in 1 BOTTLE (0003-3641-11) 30 tablet 2015-01-29 0000-00-00 No No Current