Home NDC 65162-835 Acyclovir
Product NDC 65162-835
11-digit product format 651620835
Labeler code 65162
Product ID 65162-835_5701d6c5-b948-4d7b-ab6e-99b5c559dbf5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form OINTMENT
Route TOPICAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA204605
Marketing category ANDA
Marketing start 2014-01-03
Substance ACYCLOVIR
Active strength 50 mg/g
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 A204605-001 ACYCLOVIR ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204605-001 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 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204605-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2014-06-18 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 50 mg/g
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 197312 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 65162-835-94 Acyclovir 1 in 1 CARTON OINTMENT 1 13 65162-835-94 Acyclovir 15 g in 1 TUBE OINTMENT 15 13 65162-835-96 Acyclovir 1 in 1 CARTON OINTMENT 1 13 65162-835-96 Acyclovir 30 g in 1 TUBE OINTMENT 30 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-835 ACYCLOVIR OINTMENT [AMNEAL PHARMACEUTICALS LLC] 13 Current NDC, Legacy NDC, 4 package rows 20241025_269e2203-347d-40dc-b794-11cf34690f27.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 Marketing end Sample Exclude flag Status 65162-835-94 65162083594 1 TUBE in 1 CARTON (65162-835-94) / 15 g in 1 TUBE 1 tube 2014-01-03 0000-00-00 No No Current 65162-835-96 65162083596 1 TUBE in 1 CARTON (65162-835-96) / 30 g in 1 TUBE 1 tube 2014-01-03 0000-00-00 No No Current