Home NDC 49702-207 LEXIVA
Product NDC 49702-207
11-digit product format 497020207
Labeler code 49702
Product ID 49702-207_05c0714d-c373-4321-89ac-0acb18394db1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fosamprenavir calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ViiV Healthcare Company
Application NDA021548
Marketing category NDA
Marketing start 2010-10-04
Marketing end 0000-00-00
Substance FOSAMPRENAVIR CALCIUM
Active strength 700 mg/1
Pharmacologic classes Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], P-Glycoprotein Inducers [MoA], Protease Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49702-207-18 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49702-207-18 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49702-207-18 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49702-207-18 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49702-207-18 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49702-207-18 cdf11ea48f46…ba0047e9e063…
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 N021548-001 LEXIVA FOSAMPRENAVIR CALCIUM EQ 700MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-10-20
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 N021548-001 LEXIVA EQ 700MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021548-001 LEXIVA EQ 700MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021548-001 LEXIVA EQ 700MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021548-001 LEXIVA EQ 700MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021548-001 LEXIVA EQ 700MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-10-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021548-001 LEXIVA EQ 700MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2003-10-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL RLD 2003-10-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL RLD 2003-10-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL RLD 2003-10-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL RLD 2003-10-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL RLD 2003-10-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL RLD 2003-10-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL RLD 2003-10-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL RLD 2003-10-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL RLD 2003-10-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL RLD 2003-10-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021548-001 LEXIVA EQ 700MG BASE TABLET / ORAL AB RLD, RS 2003-10-20 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 N021548-001 6514953 2019-07-15 U-257 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021548-001 6514953*PED 2020-01-15 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021548-001 6514953*PED 2020-01-15 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021548-001 6514953*PED 2020-01-15 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021548-001 6514953 2019-07-15 U-257 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021548-001 6514953*PED 2020-01-15 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021548-001 6514953 2019-07-15 U-257 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021548-001 6514953*PED 2020-01-15 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021548-001 6514953 2019-07-15 U-257 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021548-001 6514953*PED 2020-01-15 Pediatric extension ea99ee380514…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FOSAMPRENAVIR CALCIUM ACTIVE INGREDIENT ID1GU2627N LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 AMPRENAVIR ACTIVE MOIETY 5S0W860XNR LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 CALCIUM CHLORIDE INACTIVE INGREDIENT M4I0D6VV5M LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 Povidone K30 INACTIVE INGREDIENT U725QWY32X LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 WATER INACTIVE INGREDIENT 059QF0KO0R LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED LEXIVA (FOSAMPRENAVIR CALCIUM) SUSPENSION [VIIV HEALTHCARE COMPANY] 19 FOSAMPRENAVIR CALCIUM ACTIVE INGREDIENT ID1GU2627N LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 AMPRENAVIR ACTIVE MOIETY 5S0W860XNR LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49702-207-18 49702020718 60 TABLET, FILM COATED in 1 BOTTLE (49702-207-18) 2010-10-04 0000-00-00 No No Current