Home NDC 17856-0083 Acyclovir
Product NDC 17856-0083
11-digit product format 178560083
Labeler code 17856
Product ID 17856-0083_34f331d6-af84-69ea-e063-6394a90ae36e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form SUSPENSION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA074738
Marketing category ANDA
Marketing start 2002-09-03
Substance ACYCLOVIR
Active strength 200 mg/5mL
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 17856-0083 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0083 17856-0083-2 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17856-0083 17856-0083-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A074738-001 ACYCLOVIR ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074738-001 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.
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 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074738-001 ACYCLOVIR 200MG/5ML SUSPENSION / ORAL AB 1997-04-28 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 200 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X4HES1O11F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307730 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 17856-0083-1 2024-04-16 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-1 2024-04-16 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-2 2024-04-16 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-2 2024-04-16 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-1 2024-01-30 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-1 2024-01-30 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-2 2024-01-30 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-2 2024-01-30 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-1 2022-03-04 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-1 2022-03-04 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-2 2022-03-04 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-2 2022-03-04 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-1 2022-01-28 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-1 2022-01-28 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-2 2022-01-28 ACYCLOVIR ORAL SUSPENSION, USP Rx Only 17856-0083-2 2022-01-28 ACYCLOVIR ORAL SUSPENSION, USP Rx Only
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0083-1 Acyclovir 72 in 1 BOX, UNIT-DOSE SUSPENSION 72 5 17856-0083-2 Acyclovir 72 in 1 BOX, UNIT-DOSE SUSPENSION 72 5 17856-0083-3 Acyclovir 10 mL in 1 CUP, UNIT-DOSE SUSPENSION 10 5 17856-0083-4 Acyclovir 5 mL in 1 CUP, UNIT-DOSE SUSPENSION 5 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0083 ACYCLOVIR SUSPENSION [ATLANTIC BIOLOGICALS CORP.] 5 Current NDC, Legacy NDC, 4 package rows 20250514_da5a809c-6ddc-4609-9a34-ccb3d2d43976.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 Marketing end Sample Exclude flag Status 17856-0083-1 17856008301 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0083-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0083-4) 2024-04-16 0000-00-00 No No Current 17856-0083-2 17856008302 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0083-2) / 10 mL in 1 CUP, UNIT-DOSE (17856-0083-3) 2024-04-16 0000-00-00 No No Current 17856-0083-3 17856008303 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 17856-0083-4 17856008304 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical