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 3 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACYCLOVIRACYCLOVIRBryant Ranch Prepacke5356160-cb35-4ff6-91d5-2ade594e02792026-03-25Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRBryant Ranch Prepack69e5455e-d0be-4c2b-b9ab-458b5480ed572026-03-16Warnings, Adverse reactionsExact identifier
application number: ANDA210401
unii: X4HES1O11F
acyclovirACYCLOVIRREMEDYREPACK INC.8fdabab2-bc93-48ab-9c13-d22ec90fdcfc2026-02-27Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRFlorida Pharmaceutical Products, LLC3df7fa38-a869-45fb-98a3-81c5a2527d622026-02-18Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRMajor Pharmaceuticals46150f19-ce5d-42a0-80a7-f96fda2b98792026-02-18Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRPreferred Pharmaceuticals, Inc.b6d69697-12bb-4548-a6c3-2463cbf54f8f2026-02-11Warnings, Adverse reactionsExact identifier
rxcui: 197313
unii: X4HES1O11F
AcyclovirACYCLOVIRA-S Medication Solutions2e6a3667-af06-40de-80c0-8c4346e0671f2026-02-08Warnings, Adverse reactionsExact identifier
application number: ANDA210401
rxcui: 197313
unii: X4HES1O11F
AcyclovirACYCLOVIRCamber Pharmaceuticals, Inc.0910335b-6796-459f-b97e-d7ef5439a0602026-02-02Warnings, Adverse reactionsExact identifier
rxcui: 197313
unii: X4HES1O11F
acyclovirACYCLOVIRGlenmark Pharmaceuticals Inc., USA149f4418-7668-4d34-a6f9-69bf3a9c50492026-01-28Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
acyclovirACYCLOVIRANI Pharmaceuticals, Inc.8208711c-18ba-4615-b932-3c0bb7e6efae2026-01-23Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRActavis Pharma, Inc.a4c1305c-f18c-4fb0-83d8-2822341f2dfa2026-01-21Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRPreferred Pharmaceuticals Inc75334fc5-d236-401a-875c-f4f9c7749c1a2026-01-19Warnings, Adverse reactionsExact identifier
application number: ANDA210401
unii: X4HES1O11F
acyclovirACYCLOVIRPreferred Pharmaceuticals Incc11c1136-7421-48ff-86d2-39507e80a04c2026-01-15Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRPreferred Pharmaceuticals Inc.b1033fda-8242-4006-b1cd-23474d70671f2026-01-15Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRAvPAK6e203fa9-ee97-1e08-8d6a-fb57cfa13e192026-01-08Warnings, Adverse reactionsExact identifier
rxcui: 197313
unii: X4HES1O11F
AcyclovirACYCLOVIRCadila Pharmaceuticals Limiteddbaf4bf5-57e3-4770-a9b2-d47649e54c1b2026-01-02Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRNorthwind Health Company, LLC5dcfd21c-43f0-469c-be70-a4e74e6ccf882026-01-01Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRNorthwind Health Company, LLCf6f56143-ea74-af87-e053-6394a90ae3462026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197313
unii: X4HES1O11F
acyclovirACYCLOVIRNorthwind Health Company, LLCff9776b3-a248-e1ea-e053-6294a90aeb7b2026-01-01Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRYILING PHARMACEUTICAL, INC.67e7b340-0635-2595-e053-2a91aa0ad2662025-12-30Warnings, Adverse reactionsExact identifier
application number: ANDA210401
ndc (package): 69117-0019-2
ndc (package): 69117-0019-1
ndc (product): 69117-0019
ndc11 (package): 69117001901
rxcui: 197313
spl id: 4727ec9e-f954-a44e-e063-6394a90a2c04
spl set id: 67e7b340-0635-2595-e053-2a91aa0ad266
unii: X4HES1O11F

Reported adverse events (FAERS/openFDA)#

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