Home NDC 42023-173 Ganciclovir
Product NDC 42023-173
11-digit product format 420230173
Labeler code 42023
Product ID 42023-173_393ba8cf-2ed2-408b-b60e-27a9262631ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ganciclovir
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Par Health USA, LLC
Application ANDA204950
Marketing category ANDA
Marketing start 2016-12-06
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 43 .
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 A204950-001 GANCICLOVIR SODIUM GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204950-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204950-001 GANCICLOVIR EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204950-001 GANCICLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP 2016-12-06 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42023-173-01 Ganciclovir 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 10 7 42023-173-25 Ganciclovir 25 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 25 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42023-173 GANCICLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20241114_87afd103-6e64-444f-971d-0e732e9ae995.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.
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 42023-173-01 42023017301 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 42023-173-25 42023017325 25 VIAL, SINGLE-DOSE in 1 CARTON (42023-173-25) / 10 mL in 1 VIAL, SINGLE-DOSE (42023-173-01) 2016-12-06 0000-00-00 No No Current