FDA.reportPublic FDA data

NDC 70710-1137-01 - fluconazole

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
70710-1137
Requested NDC
70710-1137-01
Package NDCs from labels
70710-1137-1, 70710-1137-5, 70710-1137-4, 70710-1137-3, 70710-1137-01
Manufacturer
Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited
Effective date
2026-04-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
fluconazole - Zydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals (USA) Inc. | Zydus Lifesciences Limited2026-04-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1137-1fluconazole100 in 1 BOTTLETABLET10013
70710-1137-3fluconazole30 in 1 BOTTLETABLET3013
70710-1137-4fluconazole10 in 1 CARTONTABLET1013
70710-1137-4fluconazole10 in 1 BLISTER PACKTABLET1013
70710-1137-5fluconazole500 in 1 BOTTLETABLET50013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1137FLUCONAZOLE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]12Current NDC, Legacy NDC, 5 package rows20240306_d1364455-1537-46d4-b093-38cca3be778f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1137-3EA - Each70710-1137d5056159-abca-4273-b386-8bfcdc4c2d0412018-02-20

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 6 · 118 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLECoupler LLC519e44f4-9318-572e-e063-6394a90afe932026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEREMEDYREPACK INC.2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f52026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLECardinal Health 107, LLCf1bfba3a-5b18-41c0-9084-b1f26bb93ef22026-04-27Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLESportpharm LLC8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.eeeb82e1-d668-418e-9716-f8bcf72f80c02026-04-17Warnings, Adverse reactionsExact identifier
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.5cbd78cd-2cd7-4882-9902-bdb7812fbc6b2026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEZydus Pharmaceuticals (USA) Inc.d1364455-1537-46d4-b093-38cca3be778f2026-04-07Warnings, Adverse reactionsExact identifier
application number: ANDA208963
ndc (package): 70710-1137-1
ndc (package): 70710-1140-1
ndc (package): 70710-1139-1
ndc (package): 70710-1140-4
ndc (package): 70710-1139-5
ndc (package): 70710-1137-4
ndc (package): 70710-1138-5
ndc (package): 70710-1139-7
ndc (package): 70710-1140-5
ndc (package): 70710-1138-1
ndc (package): 70710-1138-3
ndc (package): 70710-1139-3
ndc (package): 70710-1139-8
ndc (package): 70710-1138-4
ndc (package): 70710-1137-3
ndc (package): 70710-1137-5
ndc (package): 70710-1140-3
ndc (product): 70710-1140
ndc (product): 70710-1137
ndc (product): 70710-1138
ndc (product): 70710-1139
ndc11 (package): 70710113701
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
spl id: 538304da-3971-4e3d-9ad3-af8b3dc186c3
spl set id: d1364455-1537-46d4-b093-38cca3be778f
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEMylan Pharmaceuticals Inc.737e0fac-a2d2-4053-a0d7-edbfb6248f692026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
DiflucanFLUCONAZOLERoerigf694c617-3383-416c-91b6-b94fda3712042026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEMajor Pharmaceuticals13184b13-e252-4b4d-a3e2-cfc4ad3d55b72026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197700
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEA-S Medication Solutionsf25f31a6-4bad-40fa-bced-695552e27afd2026-02-17Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLESportpharm LLC60f3e8af-d98f-48dd-83e6-a78315aaed222026-02-15Warnings, Adverse reactionsExact identifier
rxcui: 197699
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEGolden State Medical Supply, Inc.c2c7242d-d172-4733-e053-2995a90acb2e2026-02-10Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEGlenmark Pharmaceuticals Inc., USA3da5f41d-5200-45ac-b89d-00881237ec852026-01-29Warnings, Adverse reactionsExact identifier
rxcui: 197698
rxcui: 197699
rxcui: 197700
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEBryant Ranch Prepack2c9abaee-461f-437d-adda-e96d7ae3dd012026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197701
unii: 8VZV102JFY
FluconazoleFLUCONAZOLEA-S Medication Solutionsa0f1c111-e11e-4b7e-b990-8bc271cbc9402026-01-14Warnings, Adverse reactionsExact identifier
rxcui: 197698
unii: 8VZV102JFY
fluconazoleFLUCONAZOLEA-S Medication Solutions1a8bd42a-2bce-4b41-8678-67033e7707dd2026-01-13Warnings, Adverse reactionsExact identifier
application number: ANDA208963
rxcui: 197699
unii: 8VZV102JFY
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: L11K75P92J
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: L11K75P92J
Rib Cage Pain Drops 2056RIB CAGE PAIN DROPSProfessional Complementary Health Formulasf8051769-9714-4444-b736-04b95af64a9b2026-01-08WarningsExact identifier
unii: L11K75P92J

Reported adverse events (FAERS/openFDA)#

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