Home NDC 48102-028 Avaclyr
Product NDC 48102-028
11-digit product format 481020028
Labeler code 48102
Product ID 48102-028_8b20bece-92d7-4715-aad0-6eddba900c2c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACYCLOVIR
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Fera Pharmaceuticals, LLC
Application NDA202408
Marketing category NDA
Marketing start 2026-01-31
Substance ACYCLOVIR
Active strength 30 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 2027-12-31
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RS Approval date N202408-001 AVACLYR ACYCLOVIR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N202408-001 ODE-235 2026-03-29
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 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UTC 2026-02 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202408-001 AVACLYR 3% OINTMENT / OPHTHALMIC RLD 2019-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202408-001 AVACLYR 3% OINTMENT / OPHTHALMIC RLD 2019-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202408-001 AVACLYR 3% OINTMENT / OPHTHALMIC RLD 2019-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202408-001 AVACLYR 3% OINTMENT / OPHTHALMIC RLD 2019-03-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202408-001 AVACLYR 3% OINTMENT / OPHTHALMIC RLD 2019-03-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202408-001 AVACLYR 3% OINTMENT / OPHTHALMIC RLD 2019-03-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202408-001 AVACLYR 3% OINTMENT / OPHTHALMIC RLD 2019-03-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202408-001 AVACLYR 3% OINTMENT / OPHTHALMIC RLD 2019-03-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202408-001 AVACLYR 3% OINTMENT / OPHTHALMIC RLD 2019-03-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202408-001 AVACLYR 3% OINTMENT / OPHTHALMIC RLD, RS 2019-03-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202408-001 AVACLYR 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / OPHTHALMIC RLD 2019-03-29 cb3db0bc1861…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Avaclyr
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 30 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199413 Internal RxNorm lookup 2734142 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 48102-028-35 Avaclyr 3.5 g in 1 TUBE OINTMENT 3.5 3 48102-028-35 Avaclyr 1 in 1 CARTON OINTMENT 1 3
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 48102-028-35 48102002835 1 TUBE in 1 CARTON (48102-028-35) / 3.5 g in 1 TUBE 1 tube 2026-01-31 No No Current