Home NDC 63304-583 Fosamprenavir Calcium
Product NDC 63304-583
11-digit product format 633040583
Labeler code 63304
Product ID 63304-583_3397d9ea-26ac-a592-e063-6394a90ae937
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosamprenavir Calcium
Dosage form TABLET, COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA204024
Marketing category ANDA
Marketing start 2019-11-28
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 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 A204024-001 FOSAMPRENAVIR CALCIUM FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204024-001 AB
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.
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 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204024-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2019-11-20 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fosamprenavir Calcium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSAMPRENAVIR CALCIUM 700 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination ID1GU2627N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 402109 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 63304-583-01 Fosamprenavir Calcium 100 in 1 BOTTLE TABLET, COATED 100 10 63304-583-30 Fosamprenavir Calcium 30 in 1 BOTTLE TABLET, COATED 30 10 63304-583-60 Fosamprenavir Calcium 60 in 1 BOTTLE TABLET, COATED 60 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-583 FOSAMPRENAVIR CALCIUM TABLET, COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 10 Current NDC, Legacy NDC, 3 package rows 20250427_5cd1eead-9fc1-426c-bee8-214ffa7d9dc1.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 Marketing start Marketing end Sample Exclude flag Status 63304-583-01 63304058301 100 TABLET, COATED in 1 BOTTLE (63304-583-01) 2019-11-28 0000-00-00 No No Current 63304-583-30 63304058330 30 TABLET, COATED in 1 BOTTLE (63304-583-30) 2019-11-28 0000-00-00 No No Current 63304-583-60 63304058360 60 TABLET, COATED in 1 BOTTLE (63304-583-60) 2019-11-28 0000-00-00 No No Current