ATAZANAVIR

Product NDC: 70771-1593
11-digit product format: 707711593
Labeler code: 70771
Product ID: 70771-1593_7d41e669-d7c9-44b9-9470-793e56fa1776
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATAZANAVIR
Dosage form: CAPSULE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA210575
Marketing category: ANDA
Marketing start: 2021-05-04
Marketing end: 0000-00-00
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
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70771-1593		D	Discontinued by firm	2026-09-14
excluded package	package	70771-1593	70771-1593-1	D	Discontinued by firm	2026-09-14
excluded package	package	70771-1593	70771-1593-3	D	Discontinued by firm	2026-09-14

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	70771-1593		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1593	70771-1593-3	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1593	70771-1593-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A210575-001	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04
A210575-002	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04
A210575-003	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04

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 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210575-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210575-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210575-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-04	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A210575-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210575-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210575-003	AB	1	`c0c555d07b60…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1593	ATAZANAVIR CAPSULE [ZYDUS LIFESCIENCES LIMITED]	2	Legacy NDC	20221015_59417e87-cf46-4db6-975b-daf9c921098f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4MT4VIE29P	ATAZANAVIR SULFATE	229975-97-7	ATAZANAVIR SULFATE
QZU4H47A3S	ATAZANAVIR	198904-31-3	ATAZANAVIR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70771-1593-1	70771159301	100 CAPSULE in 1 BOTTLE (70771-1593-1)	100 capsule	2021-05-04	0000-00-00	No	No	Current
70771-1593-3	70771159303	30 CAPSULE in 1 BOTTLE (70771-1593-3)	30 capsule	2021-05-04	0000-00-00	No	No	Current