Home NDC 63323-315 Ganciclovir
Product NDC 63323-315
11-digit product format 633230315
Labeler code 63323
Product ID 63323-315_41a1504e-f02c-4ec1-9650-709e945234eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GANCICLOVIR SODIUM
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA090658
Marketing category ANDA
Marketing start 2010-06-28
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 2027-12-31
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 A090658-001 GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090658-001 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 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090658-001 GANCICLOVIR EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090658-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2010-06-21 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 2027-12-31 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 63323-315-01 Ganciclovir 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 8 63323-315-10 Ganciclovir 25 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 25 8 63323-315-41 Ganciclovir 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 6 63323-315-94 Ganciclovir 25 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 25 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GANCICLOVIR SODIUM ACTIVE INGREDIENT 02L083W284 GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 GANCICLOVIR ACTIVE MOIETY P9G3CKZ4P5 GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 GANCICLOVIR SODIUM ACTIVE INGREDIENT 02L083W284 GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1 GANCICLOVIR ACTIVE MOIETY P9G3CKZ4P5 GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-315 GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 7 Current NDC, Legacy NDC, 2 package rows 20221203_b47f5d1c-36b8-49b6-a410-3b3f4661dde7.zip 63323-315 GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 5 Current NDC, Legacy NDC, 2 package rows 20230115_35addab5-09db-4f8a-9c69-6fbce33ecc37.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 63323-315-01 63323031501 10 mL in 1 VIAL 10 ml Historical 63323-315-10 63323031510 25 VIAL in 1 TRAY (63323-315-10) / 10 mL in 1 VIAL (63323-315-01) 25 vial 2010-06-28 0000-00-00 No No Current 63323-315-41 63323031541 10 mL in 1 VIAL 10 ml Historical 63323-315-94 63323031594 25 VIAL in 1 TRAY (63323-315-94) / 10 mL in 1 VIAL (63323-315-41) 25 vial 2010-06-28 0000-00-00 No No Current