Home NDC 75834-123 Acyclovir
Product NDC 75834-123
11-digit product format 758340123
Labeler code 75834
Product ID 75834-123_d14fe0b4-4772-45ee-b0d9-6ea50e5c9733
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler Nivagen Pharmaceuticals, Inc.
Application ANDA202168
Marketing category ANDA
Marketing start 2016-10-15
Substance ACYCLOVIR
Active strength 800 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 2026-12-31
Current FDA listing Yes 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 75834-123 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 75834-123 75834-123-05 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 75834-123 75834-123-01 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A202168-001 ACYCLOVIR ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 A202168-002 ACYCLOVIR ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15
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 · 84 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 2026-08-18 06:07:40 2026-07 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202168-001 ACYCLOVIR 400MG TABLET / ORAL AB 2013-11-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202168-002 ACYCLOVIR 800MG TABLET / ORAL AB 2013-11-15 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 75834-123-01 2022-02-15 ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-05 2022-02-15 ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-01 2022-01-28 ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-05 2022-01-28 ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-01 2020-05-06 ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-05 2020-05-06 ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-01 2020-01-31 ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-05 2020-01-31 ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75834-123-01 Acyclovir 100 in 1 BOTTLE TABLET 100 4 75834-123-05 Acyclovir 500 in 1 BOTTLE TABLET 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75834-123 ACYCLOVIR TABLET [NIVAGEN PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20220216_7e83897b-9662-4f69-860e-da357800fc55.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 · 2 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 75834-123-01 75834012301 100 TABLET in 1 BOTTLE (75834-123-01) 100 tablet 2016-10-15 0000-00-00 No No Current 75834-123-05 75834012305 500 TABLET in 1 BOTTLE (75834-123-05) 500 tablet 2016-10-15 0000-00-00 No No Current