Atazanavir Sulfate

Product NDC
16714-860
Requested package NDC
16714-860-01
11-digit product format
167140860
Labeler code
16714
Product ID
16714-860_c5ff6121-ec6c-49b4-a722-81feecbb0bb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atazanavir
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA204806
Marketing category
ANDA
Marketing start
2019-04-08
Marketing end
0000-00-00
Substance
ATAZANAVIR SULFATE
Active strength
150 mg/1
Pharmacologic classes
HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage16714-86016714-860-01DDiscontinued by firm2026-08-03

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 · 12 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 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-860-01EA - Each16714-8602ef2e526-2639-4872-b3af-c69aa0bade5b12019-06-19

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-860-011671408600160 CAPSULE in 1 BOTTLE (16714-860-01) 60 capsule2019-04-080000-00-00NoNoCurrent