Home NDC 0378-8700 Acyclovir
Product NDC 0378-8700
11-digit product format 003788700
Labeler code 0378
Product ID 0378-8700_30e195ea-26e4-4747-9e7e-b85e0f6f68d8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acyclovir
Dosage form OINTMENT
Route TOPICAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA202459
Marketing category ANDA
Marketing start 2013-04-03
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-8700-06 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-8700-49 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0378-8700-06 f5e01cc5f278…a2eaf40c39c3…
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 A202459-001 ACYCLOVIR ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202459-001 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 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202459-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2013-04-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-8700 ACYCLOVIR OINTMENT [MYLAN PHARMACEUTICALS INC.] 12 Legacy NDC 20250101_ce3d5e8b-9401-40be-8ce7-4ea42113f4ab.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-8700-06 00378870006 1 TUBE in 1 CARTON (0378-8700-06) > 15 g in 1 TUBE 1 tube 2013-04-03 0000-00-00 No No Current 0378-8700-49 00378870049 1 TUBE in 1 CARTON (0378-8700-49) > 30 g in 1 TUBE 1 tube 2013-04-03 0000-00-00 No No Current