Home NDC 70436-089 ganciclovir
Product NDC 70436-089
11-digit product format 704360089
Labeler code 70436
Product ID 70436-089_2c55a80a-e482-1d6b-e063-6394a90a41c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ganciclovir sodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA204204
Marketing category ANDA
Marketing start 2019-01-01
Substance GANCICLOVIR SODIUM
Active strength 500 mg/10mL
Pharmacologic classes Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog Antiviral [EPC], Nucleoside Analog [EXT]
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 · 4 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 2025-01-20 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 70436-089-55 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 70436-089-55 0efc9e666f02…f202fb6c5f17…
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 A204204-001 GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204204-001 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 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204204-001 GANCICLOVIR EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204204-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2018-11-08 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 ganciclovir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GANCICLOVIR SODIUM 500 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 02L083W284 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310442 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 70436-089-55 ganciclovir 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 3 70436-089-55 ganciclovir 25 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-089 GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20250124_eb100366-2a64-4742-af11-6177a8a494c8.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70436-089-55 70436008955 25 VIAL in 1 CARTON (70436-089-55) / 10 mL in 1 VIAL 25 vial 2019-01-01 0000-00-00 No No Current