Atazanavir

Product NDC: 31722-653
11-digit product format: 317220653
Labeler code: 31722
Product ID: 31722-653_30891c38-5d64-7df7-e063-6394a90ae762
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atazanavir
Dosage form: CAPSULE
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA212278
Marketing category: ANDA
Marketing start: 2022-02-07
Substance: ATAZANAVIR SULFATE
Active strength: 150 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212278-001	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02
A212278-002	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02
A212278-003	ATAZANAVIR SULFATE	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212278-001	AB
A212278-002	AB
A212278-003	AB

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 · 96 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	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212278-002	ATAZANAVIR SULFATE	EQ 200MG BASE	CAPSULE / ORAL	AB	2022-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212278-003	ATAZANAVIR SULFATE	EQ 300MG BASE	CAPSULE / ORAL	AB	2022-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212278-001	ATAZANAVIR SULFATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2022-02-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A212278-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212278-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212278-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212278-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212278-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212278-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212278-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212278-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212278-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212278-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212278-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212278-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212278-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212278-003	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212278-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212278-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212278-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212278-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212278-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212278-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212278-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212278-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212278-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212278-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212278-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212278-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212278-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212278-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212278-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212278-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212278-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212278-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212278-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212278-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212278-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212278-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A212278-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A212278-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212278-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A212278-002	AB	1	`3bdfa0b2c4d7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Atazanavir
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATAZANAVIR SULFATE	150 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8a0c609f-e296-4925-a35c-e93a04467655	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-653-10	Atazanavir	1000 in 1 BOTTLE	CAPSULE	1000	2
31722-653-31	Atazanavir	100 in 1 CARTON	CAPSULE	100	2
31722-653-31	Atazanavir	10 in 1 BLISTER PACK	CAPSULE	10	2
31722-653-60	Atazanavir	60 in 1 BOTTLE	CAPSULE	60	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-653-60	EA - Each	31722-653	985937ea-9feb-43c2-a9d2-37eea471095a	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-653	ATAZANAVIR (ATAZANAVIR) CAPSULE [CAMBER PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 4 package rows	20250319_8a0c609f-e296-4925-a35c-e93a04467655.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
Atazanavir	ATAZANAVIR	Camber Pharmaceuticals, Inc.	8a0c609f-e296-4925-a35c-e93a04467655	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212278 application number: ANDA212278 ndc (product): 31722-653

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
402246	atazanavir sulfate 150 MG Oral Capsule	PSN	8a0c609f-e296-4925-a35c-e93a04467655	2
402247	atazanavir sulfate 200 MG Oral Capsule	PSN	8a0c609f-e296-4925-a35c-e93a04467655	2
664741	atazanavir sulfate 300 MG Oral Capsule	PSN	8a0c609f-e296-4925-a35c-e93a04467655	2
402246	atazanavir 150 MG Oral Capsule	SCD	8a0c609f-e296-4925-a35c-e93a04467655	2
402247	atazanavir 200 MG Oral Capsule	SCD	8a0c609f-e296-4925-a35c-e93a04467655	2
664741	atazanavir 300 MG Oral Capsule	SCD	8a0c609f-e296-4925-a35c-e93a04467655	2
402246	atazanavir 150 MG (as atazanavir sulfate 170.8 MG) Oral Capsule	SY	8a0c609f-e296-4925-a35c-e93a04467655	2
402247	atazanavir 200 MG (as atazanavir sulfate 227.8 MG) Oral Capsule	SY	8a0c609f-e296-4925-a35c-e93a04467655	2
664741	atazanavir 300 MG (as atazanavir sulfate 341.69 MG) Oral Capsule	SY	8a0c609f-e296-4925-a35c-e93a04467655	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-653-10	31722065310	1000 CAPSULE in 1 BOTTLE (31722-653-10)	1000 capsule	2022-02-07	0000-00-00	No	No	Current
31722-653-31	31722065331	100 BLISTER PACK in 1 CARTON (31722-653-31) / 10 CAPSULE in 1 BLISTER PACK	100 blister pack	2022-02-07	0000-00-00	No	No	Current
31722-653-60	31722065360	60 CAPSULE in 1 BOTTLE (31722-653-60)	60 capsule	2022-02-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atazanavir	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2025-03-17	HUMAN PRESCRIPTION DRUG LABEL	2