FDA.reportPublic FDA data

NDC 51672-1360-01 - 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
51672-1360
Requested NDC
51672-1360-01
Package NDCs from labels
51672-1360-1, 51672-1360-2, 51672-1360-5, 51672-1360-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-09-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acyclovir Ointment USP, 5%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-09-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1360-1Acyclovir15 g in 1 TUBEOINTMENT155
51672-1360-1Acyclovir1 in 1 CARTONOINTMENT15
51672-1360-2Acyclovir30 g in 1 TUBEOINTMENT305
51672-1360-2Acyclovir1 in 1 CARTONOINTMENT15
51672-1360-5Acyclovir1 in 1 CARTONOINTMENT15
51672-1360-5Acyclovir5 g in 1 TUBEOINTMENT55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1360ACYCLOVIR OINTMENT [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Current NDC, Legacy NDC, 6 package rows20250406_962b2e1a-ba9d-4b39-b6d1-203947166482.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1360-1GM - Gram51672-136003d1dfa6-12c1-4688-8c5e-6082116aa76f12017-03-06
51672-1360-2GM - Gram51672-13603ab83581-69ee-40d4-bb74-dd7af371494a12017-03-06

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 · 167 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
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
unii: X4HES1O11F
AcyclovirACYCLOVIRRedpharm Drug37453bcd-e34e-5902-e063-6294a90a02452025-12-13Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRChartwell RX, LLC8cd22728-34b4-4e55-8339-580138fe46d82025-12-09Warnings, Adverse reactionsExact identifier
unii: X4HES1O11F
AcyclovirACYCLOVIRCadila Pharmaceuticals Limitedacef88f4-6456-4092-993f-27e1496097c72025-12-05Warnings, Adverse reactionsExact identifier
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
unii: X4HES1O11F
acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.edb0cd28-ee57-4b60-be94-62c797fbf5e62025-11-27Warnings, Adverse reactionsExact identifier
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
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
rxcui: 197312
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
application number: ANDA205469
ndc (package): 51672-1360-1
ndc (package): 51672-1360-2
ndc (package): 51672-1360-5
ndc (product): 51672-1360
ndc11 (package): 51672136001
rxcui: 197312
spl id: 3ff34f4c-91c2-acec-e063-6394a90a722b
spl set id: 962b2e1a-ba9d-4b39-b6d1-203947166482
unii: X4HES1O11F

Reported adverse events (FAERS/openFDA)#

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