Home NDC 51817-171 Ganciclovir
Product NDC 51817-171
11-digit product format 518170171
Labeler code 51817
Product ID 51817-171_f05916fd-4785-f545-e053-2995a90aa901
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ganciclovir sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Pharmascience Inc.
Application ANDA207645
Marketing category ANDA
Marketing start 2018-04-24
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 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 A207645-001 GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207645-001 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 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2017-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207645-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 2017-12-08 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 1999531 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 51817-171-01 Ganciclovir 25 in 1 CARTON INJECTION, SOLUTION 25 9 51817-171-01 Ganciclovir 10 mL in 1 VIAL INJECTION, SOLUTION 10 9 51817-171-02 Ganciclovir 1 in 1 CARTON INJECTION, SOLUTION 1 9 51817-171-02 Ganciclovir 10 mL in 1 VIAL INJECTION, SOLUTION 10 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51817-171 GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, SOLUTION [PHARMASCIENCE INC.] 9 Current NDC, Legacy NDC, 4 package rows 20221223_3059c2da-d4a7-4aea-828c-20e671cb875c.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 51817-171-01 51817017101 25 VIAL in 1 CARTON (51817-171-01) / 10 mL in 1 VIAL 25 vial 2018-04-24 0000-00-00 No No Current 51817-171-02 51817017102 1 VIAL in 1 CARTON (51817-171-02) / 10 mL in 1 VIAL 1 vial 2019-12-15 0000-00-00 No No Current