FDA.reportPublic FDA data

NDC 80425-0319-01 - Doxycycline Monohydrate

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
80425-0319
Requested NDC
80425-0319-01
Package NDCs from labels
80425-0319-1, 80425-0319-2, 80425-0319-3, 80425-0319-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Doxycycline Monohydrate - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0319-1Doxycycline Monohydrate30 in 1 BOTTLETABLET, FILM COATED302
80425-0319-2Doxycycline Monohydrate60 in 1 BOTTLETABLET, FILM COATED602
80425-0319-3Doxycycline Monohydrate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0319DOXYCYCLINE MONOHYDRATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f91373f2-c57b-f1f1-e053-6294a90a7bdd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0319-1EA - Each80425-031953712a91-cb71-46d1-a82c-119676c6c0b412023-06-06
80425-0319-2EA - Each80425-03199cb3c160-804c-484d-b94e-9355ce488b1e12023-06-06
80425-0319-3EA - Each80425-031942cc8700-1bec-4803-b909-c7ebd869764312023-06-06

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 2 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXYCYCLINEDOXYCYCLINENorthwind Health Company, LLCf3319f4f-b535-da12-e053-2995a90ac00f2026-01-01Warnings, Adverse reactionsExact identifier
unii: N12000U13O
DoxycyclineDOXYCYCLINEChartwell RX, LLC5bebf320-1395-43b9-9404-fe479d70b2402025-12-09Warnings, Adverse reactionsExact identifier
rxcui: 1652673
rxcui: 1650142
unii: N12000U13O
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited3b9888a2-ca16-43f7-ab6d-f03188ec2c0d2025-12-02Warnings, Adverse reactionsExact identifier
rxcui: 1650444
rxcui: 1652673
rxcui: 1649429
rxcui: 1650142
unii: N12000U13O
DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.e0e80435-1b6a-4361-8c8a-e432f8f23a1b2025-10-23Warnings, Adverse reactionsExact identifier
unii: N12000U13O
DoxycyclineDOXYCYCLINESolco Healthcare US,LLC99305d9a-d058-45d6-8dec-19308b1fc5a92025-09-30Warnings, Adverse reactionsExact identifier
unii: N12000U13O
doxycyclineDOXYCYCLINEChartwell Governmental & Specialty RX, LLCb8486639-7eb9-4610-9cd4-0e922045d5922025-09-30Warnings, Adverse reactionsExact identifier
unii: N12000U13O
DoxycyclineDOXYCYCLINEStrides Pharma Science Limitedd27c58a1-5c99-4007-9bc6-ad9b6fb56db82025-09-03Warnings, Adverse reactionsExact identifier
unii: N12000U13O
DoxycyclineDOXYCYCLINEAvKARE3dd8c11c-aa52-9e22-e063-6294a90a5cbd2025-09-02Warnings, Adverse reactionsExact identifier
unii: N12000U13O
DOXYCYCLINEDOXYCYCLINEProficient Rx LP00ea3641-18da-4a6f-a779-e16075464d2b2025-09-01Warnings, Adverse reactionsExact identifier
unii: N12000U13O
Doxycycline MonohydrateDOXYCYCLINE MONOHYDRATEChartwell RX, LLC.02aa8731-d40f-43d8-8b63-a79a0503f8db2025-07-25Warnings, Adverse reactionsExact identifier
unii: N12000U13O
DoxycyclineDOXYCYCLINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2bcde264-5f6f-47f6-ae2e-1b7010deacf72025-07-18Warnings, Adverse reactionsExact identifier
rxcui: 1650444
rxcui: 1652673
rxcui: 1649429
rxcui: 1650142
unii: N12000U13O
DOXYCYCLINEDOXYCYCLINEAlembic Pharmaceuticals Inc.a50e953d-447b-4b66-b567-04586174d3f92025-06-16Warnings, Adverse reactionsExact identifier
unii: N12000U13O
doxycyclineDOXYCYCLINEMacleods Pharmaceuticals Limited10aca485-850b-4c82-bb7e-5fac2d7a62ce2025-06-07Warnings, Adverse reactionsExact identifier
unii: N12000U13O
DoxycyclineDOXYCYCLINEDr.Reddys Laboratories Inc7a28cce1-4805-b3d1-4484-e7a49c5976602025-06-06Warnings, Adverse reactionsExact identifier
unii: N12000U13O
DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.81c5a7fc-3fe0-40b2-bae0-c79eb0b276972025-06-04Warnings, Adverse reactionsExact identifier
unii: N12000U13O
DoxycyclineDOXYCYCLINEBryant Ranch Prepackb46208a2-5072-4df5-b2af-379f865545d22025-06-02Warnings, Adverse reactionsExact identifier
application number: ANDA209582
rxcui: 1650142
unii: N12000U13O
DoxycyclineDOXYCYCLINEA-S Medication Solutions2b3b3c48-eb60-400c-bdfe-50635a136c902025-05-28Warnings, Adverse reactionsExact identifier
rxcui: 1650142
unii: N12000U13O
doxycyclineDOXYCYCLINEZydus Pharmaceuticals USA Inc.fef9580d-8850-4cbb-89eb-2b4d40ee59c92025-04-26Warnings, Adverse reactionsExact identifier
unii: N12000U13O
DoxycyclineDOXYCYCLINESun Pharmaceutical Industries, Inc.829dbd3d-5c2b-47b8-96a5-423af78c93b92025-04-24Warnings, Adverse reactionsExact identifier
unii: N12000U13O
ORACEADOXYCYCLINEGalderma Laboratories, L.P.aa15c93a-ff4c-447a-8a21-96da506d89972025-04-16Warnings, Adverse reactionsExact identifier
unii: N12000U13O

Reported adverse events (FAERS/openFDA)#

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