FDA.reportPublic FDA data

NDC 80425-0280-03 - 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
80425-0280-03
Package NDCs from labels
80425-0280-1, 80425-0280-2, 80425-0280-3, 80425-0280-03
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 1 of 9 · 177 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.051654c7-8ba6-44f2-842c-72f515e9b32d2026-09-15Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
doxycycline hyclateDOXYCYCLINE HYCLATEHAWAII REPACK, INC88c429a1-351d-432e-b69b-d7a0afca482a2026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions9ecadbc8-3087-4692-916a-b7f392d8e8da2026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 1649405
unii: 19XTS3T51U
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEREMEDYREPACK INC.5fdc01c3-c62f-40cf-8351-91cbcc43d3792026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
Doxycycline hyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.df44c686-de34-487a-8741-a0a12993cab22026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.2c29f716-bdb0-437d-92a4-d856b87db9762026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.0106a3d3-db4d-f6ee-e063-6294a90a25e92026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
DoxycyclineDOXYCYCLINE HYCLATEAcella Pharmaceuticals, LLC3fb9f5ad-90a2-4858-bc34-f800d8b2fa902026-08-18Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
doxycyclineDOXYCYCLINEREMEDYREPACK INC.f0fbf63a-e75c-40cf-b2e9-429deaac899d2026-08-10Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
DoxycyclineDOXYCYCLINEAvenacy Inc.429813b4-0223-4d85-a844-b1227ff63b1e2026-08-06Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEMajor Pharmaceuticalse7c14a8e-c713-4f03-94e8-1ec9ae077d4d2026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.2305ab4a-7d08-41f6-9c39-c9b6835be3892026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
doxycyclineDOXYCYCLINEA-S Medication Solutionsfe8cd3c6-36d6-4d92-bc5c-833cd6f9cb322026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.db53637e-16ac-41b0-b9d5-553471405d642026-08-03Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
DOXYCYCLINEDOXYCYCLINELupin Pharmaceuticals, Inc.2946fc05-78e5-4669-85d1-3a3979eceae02026-08-03Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
doxycyclineDOXYCYCLINEPreferred Pharmaceuticals Inc.bcc95094-80ed-4023-b2a6-955a4810bfbe2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c2026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.3af9348c-a98b-4059-a5ef-4229e2b33af02026-07-20Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.0994d23a-f9e4-4c33-ba44-a1f4ae4a312c2026-07-20Warnings, Adverse reactionsExact identifier
application number: ANDA062676
rxcui: 1649988
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.1401d590-0967-4c6b-b52b-a83e9f6df0972026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 1650143
unii: 19XTS3T51U

Reported adverse events (FAERS/openFDA)#

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