Atazanavir Sulfate

Product NDC
51407-173
Requested package NDC
51407-173-30
11-digit product format
514070173
Labeler code
51407
Product ID
51407-173_cecd8318-1a90-67f9-e053-2995a90afde4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atazanavir Sulfate
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply Inc.
Application
ANDA091673
Marketing category
ANDA
Marketing start
2017-12-27
Marketing end
2022-03-31
Substance
ATAZANAVIR SULFATE
Active strength
300 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
0000-00-00
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 packagepackage51407-17351407-173-30DDiscontinued by firm2026-11-12

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 44.

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
A091673-001ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-22
A091673-002ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-22
A091673-003ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-22
A091673-004ATAZANAVIR SULFATEATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091673-001AB
A091673-002AB
A091673-003AB
A091673-004AB

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A091673-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-22c2088c7a36db…
2026-10-15 13:18:302026-09A091673-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-22c2088c7a36db…
2026-10-15 13:18:302026-09A091673-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-22c2088c7a36db…
2026-10-15 13:18:302026-09A091673-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-22c2088c7a36db…
2026-09-14 22:38:342026-08A091673-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A091673-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A091673-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-2284e616aacf4f…
2026-09-14 22:38:342026-08A091673-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-2284e616aacf4f…
2026-08-18 06:07:402026-07A091673-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A091673-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A091673-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A091673-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091673-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091673-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091673-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091673-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091673-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091673-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091673-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091673-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091673-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091673-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091673-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091673-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091673-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091673-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091673-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091673-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091673-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091673-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091673-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091673-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091673-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091673-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091673-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091673-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091673-001ATAZANAVIR SULFATEEQ 100MG BASECAPSULE / ORALAB2014-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091673-002ATAZANAVIR SULFATEEQ 150MG BASECAPSULE / ORALAB2014-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091673-003ATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALAB2014-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091673-004ATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALAB2014-04-222680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A091673-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091673-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091673-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A091673-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A091673-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A091673-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A091673-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A091673-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A091673-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091673-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091673-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091673-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091673-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091673-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091673-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091673-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091673-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091673-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091673-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091673-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091673-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091673-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091673-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091673-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091673-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091673-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091673-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091673-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091673-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091673-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091673-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091673-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091673-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091673-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091673-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091673-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091673-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091673-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091673-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091673-004AB12680178bc6a6…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-173-30EA - Each51407-173503cd77a-95db-45bb-bed7-2a568284bc8f12019-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-173-305140701733030 CAPSULE in 1 BOTTLE (51407-173-30) 30 capsule2017-12-272022-03-31NoNoCurrent