Home NDC 69189-3624 REYATAZ
Product NDC 69189-3624
11-digit product format 691893624
Labeler code 69189
Product ID 69189-3624_0af99050-1afd-4159-a51c-660897d575db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ATAZANAVIR
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Avera McKennan Hospital
Application NDA021567
Marketing category NDA
Marketing start 2015-04-28
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 E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69189-3624-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69189-3624-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69189-3624-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69189-3624-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69189-3624-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69189-3624-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69189-3624-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69189-3624-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69189-3624-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69189-3624-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69189-3624-1 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69189-3624-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 69189-3624-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69189-3624-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69189-3624-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 69189-3624-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 69189-3624-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 69189-3624-1 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 69189-3624-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 69189-3624-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 69189-3624-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 69189-3624-1 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 TE codes RLD / RS Approval date N021567-001 REYATAZ ATAZANAVIR SULFATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 N021567-002 REYATAZ ATAZANAVIR SULFATE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 N021567-003 REYATAZ ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 N021567-004 REYATAZ ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021567-001 REYATAZ EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021567-002 REYATAZ EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2003-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021567-003 REYATAZ EQ 200MG BASE CAPSULE / ORAL AB RLD 2003-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021567-004 REYATAZ EQ 300MG BASE CAPSULE / ORAL AB RLD, RS 2006-10-16 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 94 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021567-001 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021567-002 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021567-003 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021567-004 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021567-001 6087383*PED 2019-06-21 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021567-002 6087383*PED 2019-06-21 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021567-003 6087383*PED 2019-06-21 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021567-004 6087383*PED 2019-06-21 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021567-001 6087383*PED 2019-06-21 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021567-002 6087383*PED 2019-06-21 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021567-003 6087383*PED 2019-06-21 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021567-004 6087383*PED 2019-06-21 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021567-001 6087383*PED 2019-06-21 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021567-002 6087383*PED 2019-06-21 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021567-003 6087383*PED 2019-06-21 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021567-004 6087383*PED 2019-06-21 Pediatric extension ea99ee380514…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69189-3624-1 REYATAZ 1 in 1 DOSE PACK CAPSULE, GELATIN COATED 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69189-3624 REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED [AVERA MCKENNAN HOSPITAL] 1 Legacy NDC, 1 package rows 20170412_50ecd8f0-cb48-451c-839e-d59971a6695a.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 REYATAZ ATAZANAVIR E.R. Squibb & Sons, L.L.C. 165cff62-b284-4a27-a65d-9ec8a5bfcdd8 2024-12-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 021567 application number: NDA021567
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 69189-3624-1 69189362401 1 in 1 DOSE PACK Historical