Vistide

Product NDC
61958-0101
11-digit product format
619580101
Labeler code
61958
Product ID
61958-0101_cc1a8d88-6b17-49dd-9e47-a19a3a4b0f44
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIDOFOVIR
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gilead Sciences, Inc.
Application
NDA020638
Marketing category
NDA
Marketing start
1996-06-26
Marketing end
0000-00-00
Substance
CIDOFOVIR
Active strength
75 mg/mL
Pharmacologic classes
Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],DNA Polymerase Inhibitors [MoA],Nucleoside Analog [EXT]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61958-0101IInactivated by FDA2026-08-11
excluded packagepackage61958-010161958-0101-1IInactivated by FDA2026-08-11

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61958-0101-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61958-0101-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61958-0101-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61958-0101-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61958-0101-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61958-0101-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61958-0101-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61958-0101-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61958-0101-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61958-0101-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61958-0101-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61958-0101-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61958-0101-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61958-0101-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61958-0101-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61958-0101-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61958-0101-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61958-0101-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61958-0101-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61958-0101-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61958-0101-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61958-0101-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020638-001VISTIDECIDOFOVIREQ 375MG BASE/5ML (EQ 75MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD1996-06-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020638-001VISTIDEEQ 375MG BASE/5ML (EQ 75MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD1996-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020638-001VISTIDEEQ 375MG BASE/5ML (EQ 75MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD1996-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020638-001VISTIDEEQ 375MG BASE/5ML (EQ 75MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSRLD1996-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020638-001VISTIDEEQ 75MG BASE/MLINJECTABLE / INJECTIONRLD1996-06-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020638-001VISTIDEEQ 75MG BASE/MLINJECTABLE / INJECTIONRLD1996-06-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1996-06-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1996-06-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1996-06-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1996-06-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1996-06-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1996-06-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1996-06-263f01610625f2…
2019-09-15 20:21 UTC2019-09N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1996-06-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE / INJECTIONRLD1996-06-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020638-001VISTIDEEQ 75MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1996-06-26cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
28c2bc40-7d76-a467-8926-be43e330e768Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-0101-12020-01-31C16284748780-19d75b9d0-83f8-f424-e053-dadaa90a57ceVISTIDE ® (cidofovir injection)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-0101-1Vistide1 in 1 CARTONINJECTION16
61958-0101-1Vistide5 mL in 1 VIAL, SINGLE-USEINJECTION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-0101-1ML - Milliliter61958-0101805ef583-af92-44cd-a02c-c438c29514bc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIDOFOVIRACTIVE INGREDIENTJIL713Q00NVISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.]6
CIDOFOVIR ANHYDROUSACTIVE MOIETY768M1V522CVISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBVISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IVISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RVISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-0101VISTIDE (CIDOFOVIR) INJECTION [GILEAD SCIENCES, INC.]6Legacy NDC, 2 package rows20130928_90639fc6-0295-4115-98f0-054b783850ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199388cidofovir 375 MG in 5 ML InjectionPSN90639fc6-0295-4115-98f0-054b783850ce6
211248Vistide 375 MG in 5 ML InjectionPSN90639fc6-0295-4115-98f0-054b783850ce6
2112485 ML cidofovir 75 MG/ML Injection [Vistide]SBD90639fc6-0295-4115-98f0-054b783850ce6
1993885 ML cidofovir 75 MG/ML InjectionSCD90639fc6-0295-4115-98f0-054b783850ce6
2112485 ML Vistide 75 MG/ML InjectionSY90639fc6-0295-4115-98f0-054b783850ce6
199388cidofovir 375 MG per 5 ML InjectionSY90639fc6-0295-4115-98f0-054b783850ce6
211248Vistide 375 MG per 5 ML InjectionSY90639fc6-0295-4115-98f0-054b783850ce6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61958-0101-1619580101011 in 1 CARTONHistorical