Home NDC 84549-155 Acyclovir Sodium
Product NDC 84549-155
11-digit product format 845490155
Labeler code 84549
Product ID 84549-155_3a390591-86f7-b68d-e063-6294a90a8bcc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir Sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler ProPharma Distribution
Application ANDA203701
Marketing category ANDA
Marketing start 2013-10-11
Substance ACYCLOVIR SODIUM
Active strength 1000 mg/20mL
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 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 A203701-001 ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203701-001 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 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203701-001 ACYCLOVIR SODIUM EQ 50MG BASE/ML INJECTABLE / INJECTION AP 2013-10-11 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 Acyclovir Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR SODIUM 1000 mg/20mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 84549-155-20 Acyclovir Sodium 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84549-155 ACYCLOVIR SODIUM INJECTION, SOLUTION [PROPHARMA DISTRIBUTION] 1 Current NDC, 1 package rows 20241023_23a7cf9e-f21b-06c2-e063-6394a90aa623.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 · 3 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 84549-155-20 84549015520 20 mL in 1 VIAL, SINGLE-DOSE (84549-155-20) 20 ml 2025-08-27 No No Current