Home NDC 61958-0405 Viread
Product NDC 61958-0405
11-digit product format 619580405
Labeler code 61958
Product ID 61958-0405_1b2267fa-9978-4429-ac13-09a5d43b3093
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TENOFOVIR DISOPROXIL FUMARATE
Dosage form TABLET, COATED
Route ORAL
Labeler Gilead Sciences, Inc.
Application NDA021356
Marketing category NDA
Marketing start 2012-01-18
Substance TENOFOVIR DISOPROXIL FUMARATE
Active strength 200 mg/1
Pharmacologic classes Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 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 2025-02-02 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 61958-0405-1 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 61958-0405-1 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 61958-0405-1 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021356-001 VIREAD TENOFOVIR DISOPROXIL FUMARATE 300MG TABLET / ORAL AB RLD, RS 2001-10-26 N021356-002 VIREAD TENOFOVIR DISOPROXIL FUMARATE 150MG TABLET / ORAL AB RLD 2012-01-18 N021356-003 VIREAD TENOFOVIR DISOPROXIL FUMARATE 200MG TABLET / ORAL AB RLD 2012-01-18 N021356-004 VIREAD TENOFOVIR DISOPROXIL FUMARATE 250MG TABLET / ORAL AB RLD 2012-01-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 164 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 N021356-001 VIREAD 300MG TABLET / ORAL AB RLD, RS 2001-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021356-002 VIREAD 150MG TABLET / ORAL AB RLD 2012-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021356-003 VIREAD 200MG TABLET / ORAL AB RLD 2012-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021356-004 VIREAD 250MG TABLET / ORAL AB RLD 2012-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021356-001 VIREAD 300MG TABLET / ORAL AB RLD, RS 2001-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021356-002 VIREAD 150MG TABLET / ORAL AB RLD 2012-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021356-003 VIREAD 200MG TABLET / ORAL AB RLD 2012-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021356-004 VIREAD 250MG TABLET / ORAL AB RLD 2012-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021356-001 VIREAD 300MG TABLET / ORAL AB RLD, RS 2001-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021356-002 VIREAD 150MG TABLET / ORAL AB RLD 2012-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021356-003 VIREAD 200MG TABLET / ORAL AB RLD 2012-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021356-004 VIREAD 250MG TABLET / ORAL AB RLD 2012-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021356-001 VIREAD 300MG TABLET / ORAL AB RLD, RS 2001-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021356-002 VIREAD 150MG TABLET / ORAL AB RLD 2012-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021356-003 VIREAD 200MG TABLET / ORAL AB RLD 2012-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021356-004 VIREAD 250MG TABLET / ORAL AB RLD 2012-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021356-001 VIREAD 300MG TABLET / ORAL AB RLD, RS 2001-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021356-002 VIREAD 150MG TABLET / ORAL AB RLD 2012-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021356-003 VIREAD 200MG TABLET / ORAL AB RLD 2012-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021356-004 VIREAD 250MG TABLET / ORAL AB RLD 2012-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021356-001 VIREAD 300MG TABLET / ORAL AB RLD, RS 2001-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021356-002 VIREAD 150MG TABLET / ORAL AB RLD 2012-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021356-003 VIREAD 200MG TABLET / ORAL AB RLD 2012-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021356-004 VIREAD 250MG TABLET / ORAL AB RLD 2012-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021356-001 VIREAD 300MG TABLET / ORAL AB RLD, RS 2001-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021356-002 VIREAD 150MG TABLET / ORAL AB RLD 2012-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021356-003 VIREAD 200MG TABLET / ORAL AB RLD 2012-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021356-004 VIREAD 250MG TABLET / ORAL AB RLD 2012-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021356-001 VIREAD 300MG TABLET / ORAL AB RLD, RS 2001-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021356-002 VIREAD 150MG TABLET / ORAL AB RLD 2012-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021356-003 VIREAD 200MG TABLET / ORAL AB RLD 2012-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021356-004 VIREAD 250MG TABLET / ORAL AB RLD 2012-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021356-001 VIREAD 300MG TABLET / ORAL AB RLD, RS 2001-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021356-002 VIREAD 150MG TABLET / ORAL AB RLD 2012-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021356-003 VIREAD 200MG TABLET / ORAL AB RLD 2012-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021356-004 VIREAD 250MG TABLET / ORAL AB RLD 2012-01-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021356-001 VIREAD 300MG TABLET / ORAL AB RLD, RS 2001-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021356-002 VIREAD 150MG TABLET / ORAL AB RLD 2012-01-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021356-003 VIREAD 200MG TABLET / ORAL AB RLD 2012-01-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021356-004 VIREAD 250MG TABLET / ORAL AB RLD 2012-01-18 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 108 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Viread
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TENOFOVIR DISOPROXIL FUMARATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OTT9J7900I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349251 Internal RxNorm lookup 352050 Internal RxNorm lookup 1243227 Internal RxNorm lookup 1243229 Internal RxNorm lookup 1243324 Internal RxNorm lookup 1243326 Internal RxNorm lookup 1243328 Internal RxNorm lookup 1243330 Internal RxNorm lookup 1243343 Internal RxNorm lookup 1243346 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 61958-0405-1 Viread 30 in 1 BOTTLE, PLASTIC TABLET, COATED 30 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TENOFOVIR DISOPROXIL FUMARATE ACTIVE INGREDIENT OTT9J7900I VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 TENOFOVIR ANHYDROUS ACTIVE MOIETY W4HFE001U5 VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 HYPROMELLOSE 2910 (15000 MPA.S) INACTIVE INGREDIENT 288VBX44JC VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 MANNITOL INACTIVE INGREDIENT 3OWL53L36A VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61958-0405 VIREAD (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED VIREAD (TENOFOVIR DISOPROXIL FUMARATE) POWDER [GILEAD SCIENCES, INC.] 31 Current NDC, Legacy NDC, 1 package rows 20250223_33fd6418-fbdc-42ca-a50d-ce2a476a5418.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Viread TENOFOVIR DISOPROXIL FUMARATE Gilead Sciences, Inc. 33fd6418-fbdc-42ca-a50d-ce2a476a5418 2025-02-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021356 application number: NDA021356 ndc (product): 61958-0405
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 61958-0405-1 61958040501 30 TABLET, COATED in 1 BOTTLE, PLASTIC (61958-0405-1) 2012-01-18 0000-00-00 No No Current