FDA.reportPublic FDA data

doxycycline monohydrate 50 MG Oral Tablet

RxCUI
1652673
RxNorm name
doxycycline monohydrate 50 MG Oral Tablet
Display name
Doxycycline (Oral Pill)
Full name
doxycycline monohydrate 50 MG Oral Tablet
Term type
SCD
Status
Active
Strength
50 mg
Dose form
Tab
Route
Oral Pill
Updated
2026-10-21 07:29:27

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
072015
Active start
072015
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
doxycycline monohydrate50 MG / 1 EACHdoxycyclinedoxycycline

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Tablet317541

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
doxycycline3640

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRdoxycycline monohydrate 50 MG Oral Tablet1NAMES
RxNorm Namedoxycycline monohydrate 50 MG Oral Tablet1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
7 linked values
7CODES
RxCUI16526731CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0527-1335-010527-1335Doxycycline DoxycyclineLannett Company, Inc.ANDA065285
23155-133-0123155-133Doxycycline DoxycyclineHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDA091605
23155-133-0523155-133Doxycycline DoxycyclineHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDA091605
23155-133-1123155-133Doxycycline DoxycyclineHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDA091605
23155-133-3023155-133Doxycycline DoxycyclineHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDA091605
62135-725-2062135-725Doxycycline DoxycyclineChartwell RX, LLCANDA091605
63304-130-1063304-130Doxycycline DoxycyclineSun Pharmaceutical Industries Inc.ANDA065356
64380-205-0164380-205Doxycycline doxycyclineStrides Pharma Science LimitedANDA065070
70710-1121-170710-1121Doxycycline DoxycyclineZydus Pharmaceuticals USA Inc.ANDA209582
70771-1006-170771-1006Doxycycline DoxycyclineZydus Lifesciences LimitedANDA209582

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0652850527-1335Doxycycline DoxycyclineANDALannett Company, Inc.
ANDA09160523155-133Doxycycline DoxycyclineANDAHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
ANDA06535663304-130Doxycycline DoxycyclineANDASun Pharmaceutical Industries Inc.
ANDA06507064380-205Doxycycline doxycyclineANDAStrides Pharma Science Limited
ANDA20958270710-1121Doxycycline DoxycyclineANDAZydus Pharmaceuticals USA Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 39 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00185003601rxnav_ndcsyes
00378602101rxnav_ndcsyes
00527133501rxnav_ndcsyes
23155013301rxnav_ndcsyes
23155013305rxnav_ndcsyes
23155013311rxnav_ndcsyes
23155013330rxnav_ndcsyes
61919029960rxnav_ndcsyes
62135072520rxnav_ndcsyes
63304013010rxnav_ndcsyes
64380020501rxnav_ndcsyes
70710112101rxnav_ndcsyes
70771100601rxnav_ndcsyes
00185003605rxnav_historical_indirect
00196058302rxnav_historical_indirect
00378602105rxnav_historical_indirect
00779032215rxnav_historical_indirect
00879072450rxnav_historical_indirect
10337080001rxnav_historical
13411064003rxnav_historical_indirect
46193068705rxnav_historical_indirect
46193068706rxnav_historical_indirect
49884009101rxnav_historical
51079055720rxnav_historical_indirect
51079055741rxnav_historical_indirect
53261078907rxnav_historical_indirect
53261078908rxnav_historical_indirect
53261078909rxnav_historical_indirect
53261078910rxnav_historical_indirect
53261078912rxnav_historical_indirect
53261078913rxnav_historical_indirect
53261078914rxnav_historical_indirect
53261078920rxnav_historical_indirect
55700008628rxnav_historical
55700008630rxnav_historical
62436072801rxnav_historical_indirect
67296098901rxnav_historical
67296098902rxnav_historical
67296098907rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxycyclineDOXYCYCLINEChartwell RX, LLC5bebf320-1395-43b9-9404-fe479d70b2402025-12-09Warnings, Adverse reactionsExact identifier
ndc (package): 62135-725-20
ndc (product): 62135-725
ndc11 (package): 62135072520
rxcui: 1652673
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited3b9888a2-ca16-43f7-ab6d-f03188ec2c0d2025-12-02Warnings, Adverse reactionsExact identifier
ndc (package): 64380-205-01
ndc (product): 64380-205
ndc11 (package): 64380020501
rxcui: 1652673
DoxycyclineDOXYCYCLINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2bcde264-5f6f-47f6-ae2e-1b7010deacf72025-07-18Warnings, Adverse reactionsExact identifier
ndc (package): 23155-133-11
ndc (package): 23155-133-01
ndc (package): 23155-133-05
ndc (package): 23155-133-30
ndc (product): 23155-133
ndc11 (package): 23155013311
ndc11 (package): 23155013301
ndc11 (package): 23155013330
ndc11 (package): 23155013305
rxcui: 1652673
DoxycyclineDOXYCYCLINEZydus Pharmaceuticals USA Inc.bc321932-b600-4659-a499-1853991b4ab92025-04-10Warnings, Adverse reactionsExact identifier
ndc (package): 70710-1121-1
ndc (product): 70710-1121
ndc11 (package): 70710112101
rxcui: 1652673
DoxycyclineDOXYCYCLINELannett Company, Inc.4999bbd9-44ed-4749-9730-be2337bdf4902024-07-03Warnings, Adverse reactionsExact identifier
ndc (package): 0527-1335-01
ndc (product): 0527-1335
ndc11 (package): 00527133501
rxcui: 1652673
DoxycyclineDOXYCYCLINESun Pharmaceutical Industries Inc.8224b9c5-5c4b-4dda-bc58-47b6604c28842018-08-06Warnings, Adverse reactionsExact identifier
ndc (package): 63304-130-10
ndc (product): 63304-130
ndc11 (package): 63304013010
rxcui: 1652673

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 10 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4999bbd9-44ed-4749-9730-be2337bdf490doxycycline monohydrate 50 MG Oral Tablet [PSN] · doxycycline monohydrate 50 MG Oral Tablet [SCD]228Doxycycline Tablets, USP20240703
1cfe5aef-74f2-e780-e063-6294a90a167fdoxycycline monohydrate 50 MG Oral Tablet [PSN] · doxycycline monohydrate 50 MG Oral Tablet [SCD]223Doxycycline Tablets, USP20240711
2bcde264-5f6f-47f6-ae2e-1b7010deacf7doxycycline monohydrate 50 MG Oral Tablet [PSN] · doxycycline monohydrate 50 MG Oral Tablet [SCD]218DOXYCYCLINE TABLETS, USP Rx only20250718
bc321932-b600-4659-a499-1853991b4ab9doxycycline monohydrate 50 MG Oral Tablet [PSN] · doxycycline monohydrate 50 MG Oral Tablet [SCD]27Doxycycline Tablets, USP20250410
3b9888a2-ca16-43f7-ab6d-f03188ec2c0ddoxycycline monohydrate 50 MG Oral Tablet [PSN] · doxycycline monohydrate 50 MG Oral Tablet [SCD]26Doxycycline Tablets, USP Rx only20250321
c886b2e4-494a-4325-abaf-981fc3d01c66doxycycline monohydrate 50 MG Oral Tablet [PSN] · doxycycline monohydrate 50 MG Oral Tablet [SCD]26Doxycycline Tablets, USP20241128
8224b9c5-5c4b-4dda-bc58-47b6604c2884doxycycline monohydrate 50 MG Oral Tablet [PSN] · doxycycline monohydrate 50 MG Oral Tablet [SCD]25DOXYCYCLINE TABLETS Rx only20180806
5bebf320-1395-43b9-9404-fe479d70b240doxycycline monohydrate 50 MG Oral Tablet [PSN] · doxycycline monohydrate 50 MG Oral Tablet [SCD]23DOXYCYCLINE tablets, USP Rx only20251209
d9ad1899-5f46-4bee-a9bf-2da253e20c7cdoxycycline monohydrate 50 MG Oral Tablet [PSN] · doxycycline monohydrate 50 MG Oral Tablet [SCD]21DOXYCYCLINE20151026
bf667704-f439-4e8a-a4a5-dd150462a125doxycycline monohydrate 50 MG Oral Tablet [PSN] · doxycycline monohydrate 50 MG Oral Tablet [SCD]2120070209

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
c886b2e4-494a-4325-abaf-981fc3d01c66Doxycycline Tablets, USPZydus Lifesciences Limited20261007
5bebf320-1395-43b9-9404-fe479d70b240DOXYCYCLINE tablets, USP Rx onlyChartwell RX, LLC20251209
3b9888a2-ca16-43f7-ab6d-f03188ec2c0dDoxycycline Tablets, USP Rx onlyStrides Pharma Science Limited20251202
2bcde264-5f6f-47f6-ae2e-1b7010deacf7DOXYCYCLINE TABLETS, USP Rx onlyHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | USV Private Limited20250718
bc321932-b600-4659-a499-1853991b4ab9Doxycycline Tablets, USPZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited20250410
3b9888a2-ca16-43f7-ab6d-f03188ec2c0dDoxycycline Tablets, USP Rx onlyStrides Pharma Science Limited20250321
c886b2e4-494a-4325-abaf-981fc3d01c66Doxycycline Tablets, USPZydus Lifesciences Limited20241128
1cfe5aef-74f2-e780-e063-6294a90a167fDoxycycline Tablets, USPRedPharm Drug20240711
4999bbd9-44ed-4749-9730-be2337bdf490Doxycycline Tablets, USPLannett Company, Inc.20240703
caa9928e-8cee-408c-ac72-bd6ce1390a70DOXYCYCLINE TABLETS, USP Rx onlyLake Erie Medical DBA Quality Care Products LLC20190425
8224b9c5-5c4b-4dda-bc58-47b6604c2884DOXYCYCLINE TABLETS Rx onlySun Pharmaceutical Industries Inc. | Ohm Laboratories Inc. | Hovione PharmaScience Limited20180806
86e1102c-47bc-4f27-a4d0-7261b3deba63Doxycycline Tablets, USPPar Pharmaceutical, Inc. | Par Pharmaceutical Inc.20170809
d9ad1899-5f46-4bee-a9bf-2da253e20c7cDOXYCYCLINEDirectRX20151026
4ceb42f2-6585-4224-af3e-7d47ddfac5bbNational Council for Prescription Drug Programs20130213
b34bad0e-583b-416b-adf4-e847edfc22ceNational Council for Prescription Drug Programs20120724
1334e77b-86ce-4784-b613-f1544146c247National Council for Prescription Drug Programs20120724
7c386618-89c6-4393-bf1b-80debf22f1a6National Council for Prescription Drug Programs20120724
730d54e2-5cf3-4050-a6bb-a6d0302ceca8National Council for Prescription Drug Programs20120724
eedd02ec-26d6-4dac-9ec9-8d86534bb961National Council for Prescription Drug Programs20120724
f6d50e6b-084b-4298-8f3d-3ea28f03b8c2National Council for Prescription Drug Programs20120724
bf667704-f439-4e8a-a4a5-dd150462a125Doak Dermatologics20070209

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCA01ABAntiinfectives and antiseptics for local oral treatmentATC1-4doxycycline
ATCJ01AATetracyclinesATC1-4doxycycline
FDASPLD013754TetracyclinesCHEMhas_chemical_structuredoxycycline
FDASPLN0000175882Tetracycline-class DrugEPChas_epcdoxycycline
MEDRTD004318DoxycyclineCHEMhas_ingredientdoxycycline monohydrate
MEDRTD004318DoxycyclineCHEMhas_ingredientdoxycycline
MEDRTD013752TetracyclineCHEMci_chemclassdoxycycline
MEDRTD013752TetracyclineCHEMci_chemclassdoxycycline monohydrate
MEDRTD000881AnthraxDISEASEmay_treatdoxycycline monohydrate
MEDRTD000881AnthraxDISEASEmay_treatdoxycycline
MEDRTD002169Campylobacter InfectionsDISEASEmay_treatdoxycycline
MEDRTD002169Campylobacter InfectionsDISEASEmay_treatdoxycycline monohydrate
MEDRTD002675Child, PreschoolDISEASEci_withdoxycycline monohydrate
MEDRTD002675Child, PreschoolDISEASEci_withdoxycycline
MEDRTD002771CholeraDISEASEmay_treatdoxycycline monohydrate
MEDRTD002771CholeraDISEASEmay_treatdoxycycline
MEDRTD004342Drug HypersensitivityDISEASEci_withdoxycycline monohydrate
MEDRTD004342Drug HypersensitivityDISEASEci_withdoxycycline
MEDRTD006100Granuloma InguinaleDISEASEmay_treatdoxycycline
MEDRTD006100Granuloma InguinaleDISEASEmay_treatdoxycycline monohydrate
MEDRTD008107Liver DiseasesDISEASEci_withdoxycycline monohydrate
MEDRTD008107Liver DiseasesDISEASEci_withdoxycycline
MEDRTD008288MalariaDISEASEmay_preventdoxycycline
MEDRTD008288MalariaDISEASEmay_preventdoxycycline monohydrate
MEDRTD009175Mycoplasma InfectionsDISEASEmay_treatdoxycycline
MEDRTD009175Mycoplasma InfectionsDISEASEmay_treatdoxycycline monohydrate
MEDRTD010930PlagueDISEASEmay_treatdoxycycline
MEDRTD010930PlagueDISEASEmay_treatdoxycycline monohydrate
MEDRTD010996Pleural EffusionDISEASEmay_treatdoxycycline monohydrate
MEDRTD010996Pleural EffusionDISEASEmay_treatdoxycycline
MEDRTD018410Pneumonia, BacterialDISEASEmay_treatdoxycycline monohydrate
MEDRTD018410Pneumonia, BacterialDISEASEmay_treatdoxycycline
MEDRTD011247PregnancyDISEASEci_withdoxycycline monohydrate
MEDRTD011247PregnancyDISEASEci_withdoxycycline
MEDRTD009956PsittacosisDISEASEmay_treatdoxycycline monohydrate
MEDRTD009956PsittacosisDISEASEmay_treatdoxycycline
MEDRTD012061Relapsing FeverDISEASEmay_treatdoxycycline monohydrate
MEDRTD012061Relapsing FeverDISEASEmay_treatdoxycycline
MEDRTD012373Rocky Mountain Spotted FeverDISEASEmay_treatdoxycycline monohydrate
MEDRTD012373Rocky Mountain Spotted FeverDISEASEmay_treatdoxycycline
MEDRTD012598SclerosisDISEASEinducesdoxycycline
MEDRTD012598SclerosisDISEASEinducesdoxycycline monohydrate
MEDRTD013587SyphilisDISEASEmay_treatdoxycycline monohydrate
MEDRTD013587SyphilisDISEASEmay_treatdoxycycline
MEDRTD014141TrachomaDISEASEmay_treatdoxycycline
MEDRTD014141TrachomaDISEASEmay_treatdoxycycline monohydrate
MEDRTN0000000150Protein Synthesis InhibitorsMOAhas_moadoxycycline monohydrate
MEDRTN0000000150Protein Synthesis InhibitorsMOAhas_moadoxycycline
MEDRTN0000008334Cell Membrane AlterationPEhas_pedoxycycline monohydrate
MEDRTN0000008334Cell Membrane AlterationPEhas_pedoxycycline
MEDRTN0000008732Decreased MitosisPEhas_pedoxycycline monohydrate
MEDRTN0000008732Decreased MitosisPEhas_pedoxycycline
MEDRTN0000008841Decreased Protein SynthesisPEhas_pedoxycycline monohydrate
MEDRTN0000008841Decreased Protein SynthesisPEhas_pedoxycycline

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH50 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA065070
CODESANDAANDA065285
CODESANDAANDA065356
CODESANDAANDA091605
CODESANDAANDA209582
CODESSNOMEDCT419208003
CODESVUID4031264
NAMESPrescribable Synonymdoxycycline monohydrate 50 MG Oral Tablet
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File