Atazanavir Sulfate

Product NDC
65862-710
Requested package NDC
65862-710-39
11-digit product format
658620710
Labeler code
65862
Product ID
65862-710_8f8c56e0-40ee-4643-88f7-d3571ff5a409
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atazanavir
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204806
Marketing category
ANDA
Marketing start
2018-06-25
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
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage65862-71065862-710-39UNFINISHEDActive or certified unfinished drug listing2026-08-03

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 · 20 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204806-001ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-25
A204806-002ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-25
A204806-003ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-25
A204806-004ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204806-001AB
A204806-002AB
A204806-003AB
A204806-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204806-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204806-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204806-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204806-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204806-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204806-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204806-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204806-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204806-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204806-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204806-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204806-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204806-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204806-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204806-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204806-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204806-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204806-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204806-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204806-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204806-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204806-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204806-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204806-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204806-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204806-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204806-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204806-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204806-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204806-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204806-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204806-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204806-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204806-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204806-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204806-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204806-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2018-06-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204806-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2018-06-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204806-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2018-06-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A204806-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2018-06-25d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204806-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204806-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204806-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204806-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204806-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204806-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204806-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204806-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204806-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204806-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204806-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204806-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204806-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204806-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204806-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204806-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204806-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204806-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204806-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204806-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204806-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204806-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204806-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204806-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204806-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204806-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204806-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204806-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204806-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204806-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204806-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204806-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204806-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204806-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204806-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204806-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204806-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204806-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204806-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204806-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATAZANAVIR SULFATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4MT4VIE29PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402245Internal RxNorm lookup
402246Internal RxNorm lookup
402247Internal RxNorm lookup
664741Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7fbea274-d6b5-4faa-bbf0-05fefab42114Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7bc938bd-f454-36ec-72ed-9ef05424b276Product name820221117
248d7995-abf1-4569-b3c6-f9ebc230e8efProduct name120150323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-710-03Atazanavir Sulfate3 in 1 CARTONCAPSULE38
65862-710-05Atazanavir Sulfate500 in 1 BOTTLECAPSULE5008
65862-710-10Atazanavir Sulfate10 in 1 BLISTER PACKCAPSULE108
65862-710-60Atazanavir Sulfate60 in 1 BOTTLECAPSULE608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-710ATAZANAVIR SULFATE (ATAZANAVIR) CAPSULE [AUROBINDO PHARMA LIMITED]7Current NDC, Legacy NDC, 4 package rows20250206_7fbea274-d6b5-4faa-bbf0-05fefab42114.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atazanavir SulfateATAZANAVIRAurobindo Pharma Limited7fbea274-d6b5-4faa-bbf0-05fefab421142025-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204806
application number: ANDA204806
ndc (product): 65862-710

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402245atazanavir sulfate 100 MG Oral CapsulePSN7fbea274-d6b5-4faa-bbf0-05fefab421148
402246atazanavir sulfate 150 MG Oral CapsulePSN7fbea274-d6b5-4faa-bbf0-05fefab421148
402247atazanavir sulfate 200 MG Oral CapsulePSN7fbea274-d6b5-4faa-bbf0-05fefab421148
664741atazanavir sulfate 300 MG Oral CapsulePSN7fbea274-d6b5-4faa-bbf0-05fefab421148
402245atazanavir 100 MG Oral CapsuleSCD7fbea274-d6b5-4faa-bbf0-05fefab421148
402246atazanavir 150 MG Oral CapsuleSCD7fbea274-d6b5-4faa-bbf0-05fefab421148
402247atazanavir 200 MG Oral CapsuleSCD7fbea274-d6b5-4faa-bbf0-05fefab421148
664741atazanavir 300 MG Oral CapsuleSCD7fbea274-d6b5-4faa-bbf0-05fefab421148
402245atazanavir 100 MG (as atazanavir sulfate 113.9 MG) Oral CapsuleSY7fbea274-d6b5-4faa-bbf0-05fefab421148
402246atazanavir 150 MG (as atazanavir sulfate 170.8 MG) Oral CapsuleSY7fbea274-d6b5-4faa-bbf0-05fefab421148
402247atazanavir 200 MG (as atazanavir sulfate 227.8 MG) Oral CapsuleSY7fbea274-d6b5-4faa-bbf0-05fefab421148
664741atazanavir 300 MG (as atazanavir sulfate 341.69 MG) Oral CapsuleSY7fbea274-d6b5-4faa-bbf0-05fefab421148

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
65862-710-39658620710393000 CAPSULE in 1 BAG (65862-710-39)3000 capsule25-JUN-18Current