Home NDC 0093-5527 Atazanavir Sulfate
Product NDC 0093-5527
11-digit product format 000935527
Labeler code 0093
Product ID 0093-5527_61209ea1-63c7-43fc-ac32-d840a8a0906a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atazanavir Sulfate
Dosage form CAPSULE
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA091673
Marketing category ANDA
Marketing start 2017-12-27
Substance ATAZANAVIR SULFATE
Active strength 200 mg/1
Pharmacologic classes Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091673-001 ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 A091673-002 ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 A091673-003 ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 A091673-004 ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 164 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 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Atazanavir Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATAZANAVIR SULFATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4MT4VIE29P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 402246 Internal RxNorm lookup 402247 Internal RxNorm lookup 664741 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 0093-5527-06 Atazanavir Sulfate 60 in 1 BOTTLE CAPSULE 60 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-5527 ATAZANAVIR SULFATE CAPSULE [TEVA PHARMACEUTICALS USA, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20250403_654b7e08-33d8-47e7-b37f-3681e79c7b8b.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 Units Marketing start Marketing end Sample Exclude flag Status 0093-5527-06 00093552706 60 CAPSULE in 1 BOTTLE (0093-5527-06) 60 capsule 2017-12-27 0000-00-00 No No Current