FDA.reportPublic FDA data

NDC 10337-802 - 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
10337-802
Manufacturer
Doak Dermatologics
Effective date
2007-02-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Doxycycline Monohydrate - Doak DermatologicsDoak Dermatologics2007-02-09HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10337-802-05Doxycycline Monohydrate50 in 1 BOTTLETABLET501
10337-802-25Doxycycline Monohydrate250 in 1 BOTTLETABLET2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10337-802DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]12 package rows20070309_bf667704-f439-4e8a-a4a5-dd150462a125.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10337-802-05EA - Each10337-80249f34827-2ade-4241-84d5-05e1df4bc8ec12013-02-13
10337-802-25EA - Each10337-802f63a7d90-6417-469b-b2f0-69637de221aa12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DoxycyclineACTIVE INGREDIENTN12000U13ODOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
DoxycyclineACTIVE MOIETYN12000U13ODOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Colloidal silicon dioxideINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
D&C Yellow #10 lakeINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
FD&C Yellow #6INACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
HypromelloseINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Hypromellose 3cPINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Hypromellose 6cPINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Lactose monohydrateINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Magnesium stearateINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Microcrystalline celluloseINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Polyethylene glycol 400INACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Polysorbate 80INACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Sodium starch glycolateINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Synthetic yellow iron oxideINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1
Triethyl citrateINACTIVE INGREDIENTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) TABLET [DOAK DERMATOLOGICS]1

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 1 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEA-S Medication Solutions55873d3e-09c4-4726-acfe-5da5815895752026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 1650142
DoxycyclineDOXYCYCLINEProficient Rx LP112c35d6-a397-45de-a57a-6e687cb27b4f2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 1650142
DoxycyclineDOXYCYCLINENorthwind Health Company, LLCf2f1ee15-9323-1263-e053-2995a90a01fa2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 1650142
DoxycyclineDOXYCYCLINEChartwell RX, LLC5bebf320-1395-43b9-9404-fe479d70b2402025-12-09Warnings, Adverse reactionsExact identifier
rxcui: 1652673
rxcui: 1650142
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited3b9888a2-ca16-43f7-ab6d-f03188ec2c0d2025-12-02Warnings, Adverse reactionsExact identifier
rxcui: 1650444
rxcui: 1652673
rxcui: 1649429
rxcui: 1650142
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
DoxycyclineDOXYCYCLINEBryant Ranch Prepackb46208a2-5072-4df5-b2af-379f865545d22025-06-02Warnings, Adverse reactionsExact identifier
rxcui: 1650142
DoxycyclineDOXYCYCLINEA-S Medication Solutions2b3b3c48-eb60-400c-bdfe-50635a136c902025-05-28Warnings, Adverse reactionsExact identifier
rxcui: 1650142
DoxycyclineDOXYCYCLINEZydus Pharmaceuticals USA Inc.bc321932-b600-4659-a499-1853991b4ab92025-04-10Warnings, Adverse reactionsExact identifier
rxcui: 1650444
rxcui: 1652673
rxcui: 1649429
rxcui: 1650142
DoxycyclineDOXYCYCLINEAmerican Health Packagingadc6ba78-8dd7-47af-a7b4-c2215557696b2025-01-02Warnings, Adverse reactionsExact identifier
rxcui: 1650142
Doxycycline MonohydrateDOXYCYCLINE MONOHYDRATEAdvanced Rx Pharmacy of Tennessee, LLCf91373f2-c57b-f1f1-e053-6294a90a7bdd2024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 1650142
DoxycyclineDOXYCYCLINEBryant Ranch Prepack5f22094e-9297-4d1b-a37c-7846481b321e2024-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1650142
DoxycyclineDOXYCYCLINELannett Company, Inc.4999bbd9-44ed-4749-9730-be2337bdf4902024-07-03Warnings, Adverse reactionsExact identifier
rxcui: 1650444
rxcui: 1652673
rxcui: 1649429
rxcui: 1650142
DoxycyclineDOXYCYCLINEProficient Rx LPb83c4c4b-2885-43e7-b1c9-0b3bbf75528d2023-10-01Warnings, Adverse reactionsExact identifier
rxcui: 1650142
DoxycyclineDOXYCYCLINESun Pharmaceutical Industries Inc.8224b9c5-5c4b-4dda-bc58-47b6604c28842018-08-06Warnings, Adverse reactionsExact identifier
rxcui: 1650444
rxcui: 1652673
rxcui: 1649429
rxcui: 1650142
bf667704-f439-4e8a-a4a5-dd150462a125bf667704-f439-4e8a-a4a5-dd150462a1252007-02-09Warnings, Adverse reactionsExact identifier
spl id: bf667704-f439-4e8a-a4a5-dd150462a125
spl set id: bf667704-f439-4e8a-a4a5-dd150462a125

Reported adverse events (FAERS/openFDA)#

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