Home NDC 63010-010 VIRACEPT
Product NDC 63010-010
11-digit product format 630100010
Labeler code 63010
Product ID 63010-010_4af6d4ca-b410-48e3-925e-ce23a14db18a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nelfinavir mesylate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AGOURON
Application NDA020779
Marketing category NDA
Marketing start 1997-03-14
Substance NELFINAVIR MESYLATE
Active strength 250 mg/1
Pharmacologic classes Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [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 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.
Additional Listing Data#
Finished product Yes
Brand name base VIRACEPT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NELFINAVIR MESYLATE 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98D603VP8V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 212118 Internal RxNorm lookup 311924 Internal RxNorm lookup 403978 Internal RxNorm lookup 542370 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 63010-010-30 VIRACEPT 300 in 1 BOTTLE TABLET, FILM COATED 300 35
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 VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 NELFINAVIR ACTIVE MOIETY HO3OGH5D7I VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 CALCIUM SILICATE INACTIVE INGREDIENT S4255P4G5M VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 POTASSIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT CI71S98N1Z VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 SUCROSE PALMITATE INACTIVE INGREDIENT 3OSQ643ZK5 VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED VIRACEPT (NELFINAVIR MESYLATE) POWDER [AGOURON] 22 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 63010-010 VIRACEPT (NELFINAVIR MESYLATE) TABLET, FILM COATED [AGOURON] 34 Current NDC, Legacy NDC, 1 package rows 20240503_e72c2bc6-9462-4a2e-8e1d-b97592376cbd.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 63010-010-30 63010001030 300 TABLET, FILM COATED in 1 BOTTLE (63010-010-30) 1997-03-14 0000-00-00 No No Current