FDA.reportPublic FDA data

NDC 67457-437-00 - DOXYCYCLINE

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
67457-437
Requested NDC
67457-437-00
Package NDCs from labels
67457-437-00, 67457-437-10
Manufacturer
Henry Schein, Inc
Effective date
2025-10-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DOXYCYCLINE - Henry Schein, IncHenry Schein, Inc2025-10-24HUMAN PRESCRIPTION DRUG LABEL
Doxycycline - Mylan Institutional LLCMylan Institutional LLC2025-01-02HUMAN PRESCRIPTION DRUG LABEL
Doxycycline for Injection, USP FOR IV INFUSION ONLYGeneral Injectables & Vaccines, Inc.2022-12-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-437-00Doxycycline10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1010
67457-437-10Doxycycline10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-437DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]10Current NDC, Legacy NDC, 2 package rows20250117_878a1cf9-31a9-425b-910d-042ed91e98d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-437-00EA - Each67457-437ef6f60a1-0ef2-44bf-aa02-0736fe98e10812014-06-03
67457-437-10EA - Each67457-437784f2ff3-ae83-42bf-8f12-250de56ed41912014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ]3
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ]3
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RDOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ]3
MANNITOLINACTIVE INGREDIENT3OWL53L36ADOXYCYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC ]3

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 20 · 390 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycyclineDOXYCYCLINEPreferred Pharmaceuticals Inc.bcc95094-80ed-4023-b2a6-955a4810bfbe2026-07-30Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c2026-07-29Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
PNV-DHAASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENTAcella Pharmaceuticals, LLC038fe2e7-dc16-485c-b5fb-746db72313472026-07-23Boxed warning, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.3af9348c-a98b-4059-a5ef-4229e2b33af02026-07-20Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.0994d23a-f9e4-4c33-ba44-a1f4ae4a312c2026-07-20Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.1401d590-0967-4c6b-b52b-a83e9f6df0972026-07-17Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.b988f851-cc06-4570-9706-cf65d370bd8e2026-07-17Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.35aa295e-ff1b-453b-8eeb-65bbeda3baa52026-07-17Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Doxycyclate HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.4dc319c1-b7ef-40e4-9e66-fb24cfdefea82026-07-09Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.6e3d0691-c071-441c-9b00-22a3803050662026-07-03Warnings, Adverse reactionsExact identifier
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
unii: 19XTS3T51U
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATESt. Mary's Medical Park Pharmacy02f87c60-8425-1a1e-e063-6294a90a0c942026-06-25Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U
Minovia MiniMINOVIA MINIOncora Pharma, LLC297673c1-23db-47b5-8cfb-aaecc07908382026-06-24Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: PQ6CK8PD0R
BoosterviteMULTIVITAMINPureTek Corporation53efbf65-8844-8486-e063-6394a90a51d32026-06-18Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Doxycycline HyclateDOXYCYCLINE HYCLATEUnit Dose Solutions, Inc.548d4218-2feb-8716-e063-6394a90afbe32026-06-18Warnings, Adverse reactionsExact identifier
unii: 19XTS3T51U

Reported adverse events (FAERS/openFDA)#

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