Home NDC 71335-1013-3 Acyclovir
Product NDC 71335-1013
Requested package NDC 71335-1013-3
11-digit product format 713351013
Labeler code 71335
Product ID 71335-1013_1dc4a821-b0d6-433c-94f4-61c1a479102a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA201445
Marketing category ANDA
Marketing start 2016-10-15
Marketing end 0000-00-00
Substance ACYCLOVIR
Active strength 200 mg/1
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 2023-12-31
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 A201445-001 ACYCLOVIR ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201445-001 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 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201445-001 ACYCLOVIR 200MG CAPSULE / ORAL AB 2014-03-06 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# NDC, Related label table NDC Related label 71335-1013-0 Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc. 71335-1013-1 Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc. 71335-1013-2 Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc. 71335-1013-3 Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc. 71335-1013-4 Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc. 71335-1013-5 Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc. 71335-1013-6 Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc. 71335-1013-7 Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc. 71335-1013-8 Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc. 71335-1013-9 Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1013 ACYCLOVIR CAPSULE [BRYANT RANCH PREPACK] 4 Legacy NDC, 10 package rows 20220316_1dc4a821-b0d6-433c-94f4-61c1a479102a.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 71335-1013-3 71335101303 35 CAPSULE in 1 BOTTLE (71335-1013-3) 35 capsule 2022-03-09 0000-00-00 No No Current