Home NDC 0143-9657-10 Acyclovir
Product NDC 0143-9657
Requested package NDC 0143-9657-10
11-digit product format 001439657
Labeler code 0143
Product ID 0143-9657_dbf69540-34d6-423d-a06a-e5eddfd40ae3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA205771
Marketing category ANDA
Marketing start 2016-02-29
Substance ACYCLOVIR SODIUM
Active strength 500 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A205771-001 ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 A205771-002 ACYCLOVIR SODIUM ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29
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 3 · 82 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 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205771-001 ACYCLOVIR SODIUM EQ 500MG BASE/VIAL INJECTABLE / INJECTION 2016-02-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205771-002 ACYCLOVIR SODIUM EQ 1GM BASE/VIAL INJECTABLE / INJECTION 2016-02-29 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Acyclovir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR SODIUM 500 mg/1
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 2263503 Internal RxNorm lookup 2263505 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 0143-9657-01 Acyclovir 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 5 0143-9657-10 Acyclovir 10 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9657 ACYCLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240413_babdbce2-5cbd-4943-bc38-9ebdd696a77a.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 Marketing start Marketing end Sample Exclude flag Status 0143-9657-10 00143965710 10 VIAL, SINGLE-DOSE in 1 BOX (0143-9657-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9657-01) 2016-02-29 0000-00-00 No No Current