Home NDC 0093-5528 Atazanavir Sulfate
Product NDC 0093-5528
11-digit product format 000935528
Labeler code 0093
Product ID 0093-5528_9f855bd7-62b2-4d38-9473-c959bc810b29
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
Marketing end 2027-03-31
Substance ATAZANAVIR SULFATE
Active strength 300 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
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 176 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 2026-10-15 13:18:30 2026-09 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091673-001 ATAZANAVIR SULFATE EQ 100MG BASE CAPSULE / ORAL AB 2014-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091673-002 ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE / ORAL AB 2014-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091673-003 ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB 2014-04-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091673-004 ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB 2014-04-22 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Atazanavir Sulfate Active Ingredients# Ingredient, Strength table Ingredient Strength ATAZANAVIR SULFATE 300 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 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 0093-5528-56 Atazanavir Sulfate 30 in 1 BOTTLE CAPSULE 30 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-5528 ATAZANAVIR SULFATE CAPSULE [TEVA PHARMACEUTICALS USA, INC.] 14 Current NDC, Legacy NDC, 1 package rows 20250403_654b7e08-33d8-47e7-b37f-3681e79c7b8b.zip
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 0093-5528-56 00093552856 30 CAPSULE in 1 BOTTLE (0093-5528-56) 30 capsule 2017-12-27 2027-03-31 No No Current