Home NDC 67046-335-30 Acyclovir
Product NDC 67046-335
Requested package NDC 67046-335-30
11-digit product format 670460335
Labeler code 67046
Product ID 67046-335_a8524172-91fc-6eb2-e053-2a95a90a1cae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler Contract Pharmacy Services-PA
Application ANDA203834
Marketing category ANDA
Marketing start 2020-06-15
Marketing end 0000-00-00
Substance ACYCLOVIR
Active strength 400 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 2021-12-31
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 · 18 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…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203834-001 ACYCLOVIR ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 A203834-002 ACYCLOVIR ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 88 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 2026-10-15 13:18:30 2026-09 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203834-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-10-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203834-002 ACYCLOVIR 800MG TABLET / ORAL AB RS 2013-10-29 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 67046-335-30 Acyclovir 30 in 1 BLISTER PACK TABLET 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67046-335 ACYCLOVIR TABLET [CONTRACT PHARMACY SERVICES-PA] 1 Legacy NDC, 1 package rows 20200618_a8524172-91fb-6eb2-e053-2a95a90a1cae.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 2 of 2 · 22 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 67046-335-30 67046033530 30 TABLET in 1 BLISTER PACK (67046-335-30) 30 tablet 2020-06-15 0000-00-00 No No Current