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 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 Identifiers# Field, Values table Field Values Unii 02L083W284 Rxcui 310442
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
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