Atazanavir

Product NDC: 69238-1135
11-digit product format: 692381135
Labeler code: 69238
Product ID: 69238-1135_0564f4f6-b4d0-477e-a730-93008830bef8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atazanavir
Dosage form: CAPSULE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA209717
Marketing category: ANDA
Marketing start: 2020-06-03
Marketing end: 0000-00-00
Substance: ATAZANAVIR SULFATE
Active strength: 100 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69238-1135		D	Discontinued by firm		2026-08-03
excluded package	package	69238-1135	69238-1135-6	D	Discontinued by firm		2026-08-03

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	Approval date
A209717-001	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL	2020-06-01
A209717-002	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	2020-06-01
A209717-003	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	2020-06-01
A209717-004	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	2020-06-01

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 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2020-06-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209717-001	ATAZANAVIR SULFATE	EQ 100MG BASE	CAPSULE / ORAL		2020-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209717-002	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL		2020-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209717-003	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL		2020-06-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209717-004	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL		2020-06-01	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209717-004	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209717-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209717-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209717-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209717-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209717-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209717-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209717-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209717-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209717-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209717-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209717-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209717-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209717-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209717-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209717-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209717-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209717-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209717-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209717-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209717-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209717-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209717-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209717-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209717-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209717-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209717-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209717-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209717-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209717-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209717-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209717-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209717-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209717-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209717-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209717-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209717-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209717-002	AB	1	`c0c555d07b60…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7bc938bd-f454-36ec-72ed-9ef05424b276	Product name	8	20221117
248d7995-abf1-4569-b3c6-f9ebc230e8ef	Product name	1	20150323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1135	ATAZANAVIR CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]	9	Legacy NDC	20250205_b670a844-3bbf-4d9a-9904-87992f26792d.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
69238-1135-6	69238113506	60 CAPSULE in 1 BOTTLE (69238-1135-6)	60 capsule	2020-06-03	0000-00-00	No	No	Current