Home NDC 0003-3638 REYATAZ
Product NDC 0003-3638
11-digit product format 000033638
Labeler code 0003
Product ID 0003-3638_510c2d51-4943-401c-a008-ea22f61c6938
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ATAZANAVIR
Dosage form POWDER
Route ORAL
Labeler E.R. Squibb & Sons, L.L.C.
Application NDA206352
Marketing category NDA
Marketing start 2014-12-19
Substance ATAZANAVIR SULFATE
Active strength 50 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206352-001 REYATAZ ATAZANAVIR SULFATE EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02
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 2 · 41 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 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206352-001 REYATAZ EQ 50MG BASE/PACKET POWDER / ORAL RLD, RS 2014-06-02 cb3db0bc1861…
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 N206352-001 6087383*PED 2019-06-21 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N206352-001 6087383*PED 2019-06-21 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206352-001 6087383*PED 2019-06-21 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206352-001 6087383*PED 2019-06-21 Pediatric extension ea99ee380514…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N206352-001 PED 2019-03-24 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N206352-001 PED 2019-03-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206352-001 PED 2019-03-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206352-001 PED 2019-03-24 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base REYATAZ
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATAZANAVIR SULFATE 50 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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 402093 Internal RxNorm lookup 402094 Internal RxNorm lookup 402246 Internal RxNorm lookup 402247 Internal RxNorm lookup 664741 Internal RxNorm lookup 664743 Internal RxNorm lookup 1598985 Internal RxNorm lookup 1598989 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0003-3638-10 REYATAZ 1 in 1 PACKET POWDER 1 37 0003-3638-10 REYATAZ 30 in 1 CARTON POWDER 30 37
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATAZANAVIR SULFATE ACTIVE INGREDIENT 4MT4VIE29P REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 ATAZANAVIR ACTIVE MOIETY QZU4H47A3S REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 ALCOHOL INACTIVE INGREDIENT 3K9958V90M REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 AMMONIA INACTIVE INGREDIENT 5138Q19F1X REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 GELATIN INACTIVE INGREDIENT 2G86QN327L REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 SHELLAC INACTIVE INGREDIENT 46N107B71O REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 SUCROSE INACTIVE INGREDIENT C151H8M554 REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0003-3638 REYATAZ (ATAZANAVIR) CAPSULE, GELATIN COATED REYATAZ (ATAZANAVIR) POWDER [E.R. SQUIBB & SONS, L.L.C.] 36 Current NDC, Legacy NDC, 2 package rows 20241220_165cff62-b284-4a27-a65d-9ec8a5bfcdd8.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0003-3638-10 00003363810 30 PACKET in 1 CARTON (0003-3638-10) / 1 POWDER in 1 PACKET 30 packet 2014-12-19 0000-00-00 No No Current