Home NDC 0378-3520 Fosamprenavir Calcium
Product NDC 0378-3520
11-digit product format 003783520
Labeler code 0378
Product ID 0378-3520_88dccf91-6e62-4f5f-849d-1ffa8bf8df9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fosamprenavir calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA204060
Marketing category ANDA
Marketing start 2017-09-18
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 A204060-001 FOSAMPRENAVIR CALCIUM FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204060-001 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.
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 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB RS 2016-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204060-001 FOSAMPRENAVIR CALCIUM EQ 700MG BASE TABLET / ORAL AB 2016-04-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fosamprenavir Calcium
Listing expiration 2026-12-31 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 0378-3520-91 Fosamprenavir Calcium 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-3520 FOSAMPRENAVIR CALCIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 Current NDC, Legacy NDC, 1 package rows 20231030_3a1424d8-844c-4e24-9ebd-b2c2b61b61a3.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 0378-3520-91 00378352091 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3520-91) 2017-09-18 0000-00-00 No No Current