Home NDC 46708-248-30 Acyclovir
Product NDC 46708-248
Requested package NDC 46708-248-30
11-digit product format 467080248
Labeler code 46708
Product ID 46708-248_f5dd9ff3-9b21-40f8-8abf-ec2f151c90e4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form OINTMENT
Route CUTANEOUS
Labeler Alembic Pharmaceuticals Limited
Application ANDA209000
Marketing category ANDA
Marketing start 2018-04-16
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 2020-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 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 A209000-001 ACYCLOVIR ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209000-001 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 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209000-001 ACYCLOVIR 5% OINTMENT / TOPICAL AB 2018-04-06 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-248-30 Acyclovir 1 in 1 CARTON OINTMENT 1 3 46708-248-30 Acyclovir 30 g in 1 TUBE OINTMENT 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-248 ACYCLOVIR OINTMENT [ALEMBIC PHARMACEUTICALS LIMITED] 3 Legacy NDC, 2 package rows 20191010_2bcc878f-4c86-4a16-85cf-f9963e0f725b.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acyclovir ACYCLOVIR Alembic Pharmaceuticals Inc. 5adf2205-5493-4e7a-bf50-01f4eb661dd8 2025-03-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 209000 application number: ANDA209000
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 46708-248-30 46708024830 1 TUBE in 1 CARTON (46708-248-30) > 30 g in 1 TUBE 1 tube 2018-04-16 0000-00-00 No No Current