Home NDC 53808-1010 LEXIVA
Product NDC 53808-1010
11-digit product format 538081010
Labeler code 53808
Product ID 53808-1010_7c778d60-3b61-4b2b-9cf7-1a6b4ad3b7db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fosamprenavir calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application NDA021548
Marketing category NDA
Marketing start 2014-11-01
Marketing end 0000-00-00
Substance FOSAMPRENAVIR CALCIUM
Active strength 700 mg/1
Pharmacologic classes Protease Inhibitor [EPC],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A4 Inducers [MoA],P-Glycoprotein Inducers [MoA],HIV Protease Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 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 53808-1010-1 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 53808-1010-1 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 53808-1010-1 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 53808-1010-1 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 53808-1010-1 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 53808-1010-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53808-1010-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53808-1010-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53808-1010-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53808-1010-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53808-1010-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 53808-1010-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 53808-1010-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 53808-1010-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 53808-1010-1 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 53808-1010-1 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 53808-1010-1 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 53808-1010-1 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 53808-1010-1 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53808-1010-1 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53808-1010-1 9bebd1f3094a…5416666fcb17…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53808-1010-1 LEXIVA 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
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 [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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-1010 LEXIVA (FOSAMPRENAVIR CALCIUM) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20150113_b919bb7e-75f8-4df4-924c-54e829be0607.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-1010-1 53808101001 30 in 1 BLISTER PACK Historical