Home NDC 67457-210 CIDOFOVIR
Product NDC 67457-210
11-digit product format 674570210
Labeler code 67457
Product ID 67457-210_e7774227-c6ba-439d-a32f-01b67d010fc5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cidofovir Anhydrous
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA201276
Marketing category ANDA
Marketing start 2013-06-03
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 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 A201276-001 CIDOFOVIR CIDOFOVIR EQ 375MG BASE/5ML (EQ 75MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2012-06-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201276-001 AP
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 A201276-001 CIDOFOVIR EQ 375MG BASE/5ML (EQ 75MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2012-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201276-001 CIDOFOVIR EQ 375MG BASE/5ML (EQ 75MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2012-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201276-001 CIDOFOVIR EQ 375MG BASE/5ML (EQ 75MG BASE/ML) SOLUTION / INTRAVENOUS AP RS 2012-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201276-001 CIDOFOVIR EQ 75MG BASE/ML INJECTABLE / INJECTION AP RS 2012-06-27 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 CIDOFOVIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIDOFOVIR 75 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JIL713Q00N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199388 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 67457-210-05 CIDOFOVIR 1 in 1 CARTON INJECTION, SOLUTION 1 8 67457-210-05 CIDOFOVIR 5 mL in 1 VIAL, GLASS INJECTION, SOLUTION 5 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-210 CIDOFOVIR (CIDOFOVIR ANHYDROUS) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 8 Current NDC, Legacy NDC, 2 package rows 20210714_56541229-8c1a-4550-8951-2415ed08e7e9.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 CIDOFOVIR CIDOFOVIR ANHYDROUS Mylan Institutional LLC 56541229-8c1a-4550-8951-2415ed08e7e9 2021-04-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201276 application number: ANDA201276 ndc (product): 67457-210
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 67457-210-05 67457021005 1 VIAL, GLASS in 1 CARTON (67457-210-05) / 5 mL in 1 VIAL, GLASS 2013-06-03 0000-00-00 No No Current