Home NDC 71921-210 Valganciclovir
Product NDC 71921-210
11-digit product format 719210210
Labeler code 71921
Product ID 71921-210_cc6c4939-7908-439c-b1b8-6b52e826c7a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valganciclovir
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Florida Pharmaceutical Products, LLC
Application ANDA216317
Marketing category ANDA
Marketing start 2023-07-01
Substance VALGANCICLOVIR
Active strength 50 mg/mL
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 42 .
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 A216317-001 VALGANCICLOVIR HYDROCHLORIDE VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216317-001 AB
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.
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 2026-08-18 06:07:40 2026-07 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216317-001 VALGANCICLOVIR HYDROCHLORIDE 50MG/ML FOR SOLUTION / ORAL AB 2023-04-11 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Valganciclovir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALGANCICLOVIR 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GCU97FKN3R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 863559 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 71921-210-12 Valganciclovir 100 mL in 1 BOTTLE POWDER, FOR SOLUTION 100 1 71921-210-12 Valganciclovir 1 in 1 CARTON POWDER, FOR SOLUTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71921-210 VALGANCICLOVIR POWDER, FOR SOLUTION [FLORIDA PHARMACEUTICAL PRODUCTS, LLC] 1 Current NDC, 2 package rows 20230714_cc6c4939-7908-439c-b1b8-6b52e826c7a5.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 Sample Exclude flag Status 71921-210-12 71921021012 1 BOTTLE in 1 CARTON (71921-210-12) / 100 mL in 1 BOTTLE 1 bottle 2023-07-01 No No Current