FDA.reportPublic FDA data

NDC 80425-0280-01 - Doxycycline Hyclate

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
80425-0280
Requested NDC
80425-0280-01
Package NDCs from labels
80425-0280-1, 80425-0280-2, 80425-0280-3, 80425-0280-01
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 Hyclate - 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
80425-0280-1Doxycycline Hyclate10 in 1 BOTTLECAPSULE103
80425-0280-2Doxycycline Hyclate20 in 1 BOTTLECAPSULE203
80425-0280-3Doxycycline Hyclate14 in 1 BOTTLECAPSULE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0280DOXYCYCLINE HYCLATE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 3 package rows20250102_f5ed9293-15f8-ecfa-e053-2a95a90ab6a4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0280-1EA - Each80425-0280876b650e-7c89-412c-845c-a5193b5fea3712023-04-07
80425-0280-2EA - Each80425-0280c97ffa83-0b17-44a7-8839-7bcf1d46380212023-04-07
80425-0280-3EA - Each80425-028073733f95-7ccf-4f1e-b42a-76fe950577ab12023-07-06

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 9 · 176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.b988f851-cc06-4570-9706-cf65d370bd8e2026-07-17Warnings, Adverse reactionsExact identifier
application number: ANDA062676
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.35aa295e-ff1b-453b-8eeb-65bbeda3baa52026-07-17Warnings, Adverse reactionsExact identifier
application number: ANDA062676
rxcui: 1649988
unii: 19XTS3T51U
Doxycyclate HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.4dc319c1-b7ef-40e4-9e66-fb24cfdefea82026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.6e3d0691-c071-441c-9b00-22a3803050662026-07-03Warnings, Adverse reactionsExact identifier
application number: ANDA062676
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEChartwell RX, LLCfad03768-f1d2-459f-965e-0ec29f189f1f2026-06-30Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEStrides Pharma Science Limited2deeee4f-b342-a178-e063-6394a90af8972026-06-26Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEStrides Pharma Science Limitedb8b76aaa-575b-497f-b854-c42bc992c7842026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATESt. Mary's Medical Park Pharmacy02f87c60-8425-1a1e-e063-6294a90a0c942026-06-25Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEUnit Dose Solutions, Inc.548d4218-2feb-8716-e063-6394a90afbe32026-06-18Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
DoxycyclineDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.c96d3986-9d92-4ec4-a319-a50aeb2f4fe72026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.e24a3292-0d4f-4692-8cf7-a82bd19e59322026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.5f523294-e62b-4da5-8799-047d4bed966f2026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATESun Pharmaceutical Industries, Inc.214a9cfe-a522-4022-81d4-e59f447401fe2026-06-03Warnings, Adverse reactionsExact identifier
application number: ANDA062676
ndc (product): 53489-119
rxcui: 1649988
rxcui: 1649405
rxcui: 1650143
spl id: 53577734-d479-e32b-e063-6394a90a7933
spl set id: 214a9cfe-a522-4022-81d4-e59f447401fe
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATECoupler LLC52ba329a-8cb3-cf30-e063-6394a90aa0dc2026-05-26Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
doxycyclineDOXYCYCLINEREMEDYREPACK INC.d3c0b756-30ba-4ef9-a178-fd785d7203732026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.3a85933f-bd73-4ad7-968d-c90cb7c7a60c2026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
doxycyclineDOXYCYCLINEST. MARY'S MEDICAL PARK PHARMACY00b2aa98-dea2-90c3-e063-6294a90a35d62026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEAlembic Pharmaceuticals Inc.3ae4ca12-be39-46b9-bc4c-f8356776c1752026-04-28Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATECardinal Health 107, LLCa34fbbc7-09dc-42d6-a075-f4ea8f170ba72026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEBryant Ranch Prepack7a915c50-6fce-45e6-9554-677bb09a868d2026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U

Reported adverse events (FAERS/openFDA)#

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