FDA.reportPublic FDA data

NDC 69117-0019-01 - Acyclovir

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
69117-0019
Requested NDC
69117-0019-01
Package NDCs from labels
69117-0019-1, 69117-0019-2, 69117-0019-01
Manufacturer
YILING PHARMACEUTICAL, INC.
Effective date
2025-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acyclovir - YILING PHARMACEUTICAL, INC.YILING PHARMACEUTICAL, INC.2025-12-30HUMAN PRESCRIPTION DRUG LABEL
Acyclovir - Bryant Ranch PrepackBryant Ranch Prepack2025-01-30HUMAN PRESCRIPTION DRUG LABEL
ACYCLOVIR TABLETS, USP 800 mgRedpharm Drug, inc.2024-08-07HUMAN PRESCRIPTION DRUG LABEL
Acyclovir - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2021-02-22HUMAN PRESCRIPTION DRUG LABEL
Acyclovir - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-02-17HUMAN PRESCRIPTION DRUG LABEL
Acyclovir - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2020-09-14HUMAN PRESCRIPTION DRUG LABEL
Acyclovir - REMEDYREPACK INC.REMEDYREPACK INC.2019-04-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69117-0019-1Acyclovir100 in 1 BOTTLETABLET1006
69117-0019-2Acyclovir500 in 1 BOTTLETABLET5006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0019ACYCLOVIR TABLET [YILING PHARMACEUTICAL, INC.]5Current NDC, Legacy NDC, 2 package rows20250101_67e7b340-0635-2595-e053-2a91aa0ad266.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69117-0019-1EA - Each69117-0019df9ed45f-6070-455c-aa96-c825a973234112018-09-05
69117-0019-2EA - Each69117-001969ac961d-b9af-4fe3-a410-c7d4e674013f12018-09-05

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 4 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRYILING PHARMACEUTICAL, INC.8542495c-eef1-448b-abb5-83cb1ac589f72025-12-30Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRYILING PHARMACEUTICAL, INC.677edfd5-2d04-b932-e053-2a91aa0a26b02025-12-30Warnings, Adverse reactionsExact identifier
application number: ANDA210401
unii: X4HES1O11F
AcyclovirACYCLOVIRChartwell Governmental & Specialty RX, LLC.2757bb30-3374-4e1b-b496-14874f7ec6232025-12-23Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRChartwell RX, LLC7d2a75a5-233f-46dd-9cb0-3918ea53e5542025-12-18Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
ACYCLOVIRACYCLOVIRAurobindo Pharma Limitedcfee4476-a3c9-4e0c-a235-c68c5d46931e2025-12-16Warnings, Adverse reactionsExact identifier
rxcui: 197313
unii: X4HES1O11F
AcyclovirACYCLOVIRRedpharm Drug37453bcd-e34e-5902-e063-6294a90a02452025-12-13Warnings, Adverse reactionsExact identifier
application number: ANDA210401
unii: X4HES1O11F
AcyclovirACYCLOVIRChartwell RX, LLC8cd22728-34b4-4e55-8339-580138fe46d82025-12-09Warnings, Adverse reactionsExact identifier
application number: ANDA210401
rxcui: 197313
unii: X4HES1O11F
AcyclovirACYCLOVIRCadila Pharmaceuticals Limitedacef88f4-6456-4092-993f-27e1496097c72025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 197313
unii: X4HES1O11F
ACYCLOVIRACYCLOVIRAurobindo Pharma Limited37761c4f-4378-472e-a41b-6a1d40575cb72025-12-03Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
acyclovirACYCLOVIRViona Pharmaceuticals Ince580b7e9-9060-43f5-9b58-33998078d7e42025-12-02Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRAdvagen Pharma Limited6a9ea291-4ad5-48a8-8c08-5a17c87575492025-11-27Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
acyclovirACYCLOVIRZydus Lifesciences Limited8d9fea43-6c04-40d7-8aac-398c2de2a5582025-11-27Warnings, Adverse reactionsExact identifier
rxcui: 197313
unii: X4HES1O11F
acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.edb0cd28-ee57-4b60-be94-62c797fbf5e62025-11-27Warnings, Adverse reactionsExact identifier
rxcui: 197313
unii: X4HES1O11F
acyclovirACYCLOVIRZydus Lifesciences Limited395cd839-21e1-43e2-a8ce-078f07bc76682025-11-22Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
acyclovirACYCLOVIRApotex Corp.7fdeb609-24c4-5024-52c3-6a32bc7f3fcc2025-11-20Warnings, Adverse reactionsExact identifier
rxcui: 197313
unii: X4HES1O11F
ACYCLOVIRACYCLOVIRApotex Corp.41bea43a-f58c-2c6f-4d31-406ceb4560772025-11-17Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRTeva Pharmaceuticals USA, Inc.103f29b8-2c13-4917-a446-59d3246d48d12025-10-23Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
acyclovirACYCLOVIRNuCare Pharmaceuticals, Inc.41d5ae3e-51c0-263b-e063-6394a90a33122025-10-23Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRATLANTIC BIOLOGICALS CORP.4032ce02-e2b3-d426-e063-6294a90ab6c92025-10-01Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRSun Pharmaceutical Industries, Inc.962b2e1a-ba9d-4b39-b6d1-2039471664822025-09-29Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.