Home NDC 65219-622 acyclovir
Product NDC 65219-622
11-digit product format 652190622
Labeler code 65219
Product ID 65219-622_a2fee863-ed62-4501-881d-eab609ebd51d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACYCLOVIR
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA215404
Marketing category ANDA
Marketing start 2024-12-16
Substance ACYCLOVIR SODIUM
Active strength 50 mg/mL
Pharmacologic classes DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [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 A215404-001 ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215404-001 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.
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 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION 2024-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215404-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2024-06-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base acyclovir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR SODIUM 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 927L42J563 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1734932 Internal RxNorm lookup 1734934 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 65219-622-02 acyclovir 10 mL in 1 VIAL INJECTION, SOLUTION 10 1 65219-622-10 acyclovir 10 in 1 CARTON INJECTION, SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-622 ACYCLOVIR INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 Current NDC, 2 package rows 20241217_b1bb347d-74f4-4976-8450-a375a271718f.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 65219-622-02 65219062202 10 mL in 1 VIAL 10 ml Historical 65219-622-10 65219062210 10 VIAL in 1 CARTON (65219-622-10) / 10 mL in 1 VIAL (65219-622-02) 10 vial 2024-12-16 No No Current