Home NDC 52959-289 VIRACEPT
Product NDC 52959-289
11-digit product format 529590289
Labeler code 52959
Product ID 52959-289_a0862d45-3327-433a-9d0d-2928a4327527
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nelfinavir mesylate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application NDA020779
Marketing category NDA
Marketing start 1997-03-14
Marketing end 0000-00-00
Substance NELFINAVIR MESYLATE
Active strength 250 mg/1
Pharmacologic classes HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N020779-001 VIRACEPT NELFINAVIR MESYLATE EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14
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 · 43 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 2026-09-14 22:38:34 2026-08 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020779-001 VIRACEPT EQ 250MG BASE TABLET / ORAL RLD, RS 1997-03-14 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 52959-289-06 VIRACEPT 6 in 1 BOTTLE TABLET, FILM COATED 6 3 52959-289-30 VIRACEPT 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded nelfinavir mesylate ACTIVE INGREDIENT 98D603VP8V VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 nelfinavir ACTIVE MOIETY HO3OGH5D7I VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 calcium silicate INACTIVE INGREDIENT S4255P4G5M VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 crospovidone INACTIVE INGREDIENT 68401960MK VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 FD&C blue No. 2 INACTIVE INGREDIENT L06K8R7DQK VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 triacetin INACTIVE INGREDIENT XHX3C3X673 VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-289 VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.] 3 Legacy NDC, 2 package rows 20120420_303c9bc8-eaff-4a65-9c60-7de6bddec348.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 Status 52959-289-06 52959028906 6 in 1 BOTTLE Historical 52959-289-30 52959028930 30 in 1 BOTTLE Historical