FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
62135-626
11-digit product format
621350626
Labeler code
62135
Product ID
62135-626_40077986-5ebb-f8f0-e063-6394a90ad09f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX LLC
Application
ANDA062505
Marketing category
ANDA
Marketing start
1984-09-11
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN12000U13O, 19XTS3T51U
Rxcui1649405, 1649988, 1650030, 1650143, 1652674

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-626-01Doxycycline Hyclate100 in 1 BOTTLETABLET, FILM COATED10016
62135-626-05Doxycycline Hyclate500 in 1 BOTTLETABLET, FILM COATED50016
62135-626-10Doxycycline Hyclate1000 in 1 BOTTLETABLET, FILM COATED100016
62135-626-12Doxycycline Hyclate120 in 1 BOTTLETABLET, FILM COATED12016
62135-626-20Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED2016
62135-626-23Doxycycline Hyclate210 in 1 BOTTLETABLET, FILM COATED21016
62135-626-28Doxycycline Hyclate28 in 1 BOTTLETABLET, FILM COATED2816
62135-626-31Doxycycline Hyclate300 in 1 BOTTLETABLET, FILM COATED30016
62135-626-40Doxycycline Hyclate400 in 1 BOTTLETABLET, FILM COATED40016
62135-626-50Doxycycline Hyclate50 in 1 BOTTLETABLET, FILM COATED5016
62135-626-96Doxycycline Hyclate2000 in 1 BOTTLETABLET, FILM COATED200016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-626-05EA - Each62135-626d2c1888c-10a9-40c0-96b3-46cb70b712b712019-07-02
62135-626-50EA - Each62135-6262c5eb5a0-45d6-4894-a636-16e73d7a9b7c12019-07-02
62135-626-96EA - Each62135-62646c6e601-1749-47e5-b27e-d54848d1379112021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
stearic acidINACTIVE INGREDIENT4ELV7Z65APDOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE TABLET, FILM COATED [CHARTWELL RX LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-626DOXYCYCLINE HYCLATE TABLET, FILM COATED DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE POWDER, FOR SUSPENSION [CHARTWELL RX LLC]15Current NDC, Legacy NDC, 11 package rows20240402_3e7cf78f-3b48-4614-9fa4-c6d1e0c05a35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650143doxycycline hyclate 100 MG Oral TabletPSN3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1649405doxycycline hyclate 50 MG Oral CapsulePSN3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1652674doxycycline hyclate 50 MG Oral TabletPSN3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650030doxycycline monohydrate 25 MG in 5 mL Oral SuspensionPSN3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1649988doxycycline hyclate 100 MG Oral CapsuleSCD3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650143doxycycline hyclate 100 MG Oral TabletSCD3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1649405doxycycline hyclate 50 MG Oral CapsuleSCD3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1652674doxycycline hyclate 50 MG Oral TabletSCD3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650030doxycycline monohydrate 5 MG/ML Oral SuspensionSCD3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650030doxycycline monohydrate 25 MG per 5 ML Oral SuspensionSY3e7cf78f-3b48-4614-9fa4-c6d1e0c05a3516
1650143doxycycline hyclate 100 MG Oral TabletPSNb70a3a12-76a2-4558-bf2c-eaa38a9ba0a012
1650143doxycycline hyclate 100 MG Oral TabletSCDb70a3a12-76a2-4558-bf2c-eaa38a9ba0a012
1650143doxycycline hyclate 100 MG Oral TabletPSNa84d7562-08bf-417f-a599-ba0d17c5523211
1650143doxycycline hyclate 100 MG Oral TabletSCDa84d7562-08bf-417f-a599-ba0d17c5523211
1650143doxycycline hyclate 100 MG Oral TabletPSN98bf51e7-01f8-e3f7-e053-2995a90a42f010
1650143doxycycline hyclate 100 MG Oral TabletSCD98bf51e7-01f8-e3f7-e053-2995a90a42f010
1650143doxycycline hyclate 100 MG Oral TabletPSNa707c9e3-00eb-e832-e053-2a95a90a5f584
1650143doxycycline hyclate 100 MG Oral TabletSCDa707c9e3-00eb-e832-e053-2a95a90a5f584
1650143doxycycline hyclate 100 MG Oral TabletPSN09d19663-a8b9-0c3f-e063-6394a90aa4463
1650143doxycycline hyclate 100 MG Oral TabletSCD09d19663-a8b9-0c3f-e063-6394a90aa4463
1650143doxycycline hyclate 100 MG Oral TabletPSNb56dffde-1334-f5a0-e053-2a95a90a717c2
1650143doxycycline hyclate 100 MG Oral TabletSCDb56dffde-1334-f5a0-e053-2a95a90a717c2
1650143doxycycline hyclate 100 MG Oral TabletPSNdd7672c9-b10f-4ea1-9000-ef3e3faa10db1
1650143doxycycline hyclate 100 MG Oral TabletPSNf23f40a6-08b8-4717-9284-fb7f68fa07e51
1650143doxycycline hyclate 100 MG Oral TabletPSNf4239c08-f324-61f8-e053-2995a90adebe1
1650143doxycycline hyclate 100 MG Oral TabletSCDdd7672c9-b10f-4ea1-9000-ef3e3faa10db1
1650143doxycycline hyclate 100 MG Oral TabletSCDf23f40a6-08b8-4717-9284-fb7f68fa07e51
1650143doxycycline hyclate 100 MG Oral TabletSCDf4239c08-f324-61f8-e053-2995a90adebe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62135-626-0162135062601100 TABLET, FILM COATED in 1 BOTTLE (62135-626-01) 2020-09-010000-00-00NoNoCurrent
62135-626-0562135062605500 TABLET, FILM COATED in 1 BOTTLE (62135-626-05) 1984-09-110000-00-00NoNoCurrent
62135-626-10621350626101000 TABLET, FILM COATED in 1 BOTTLE (62135-626-10) 2020-01-010000-00-00NoNoCurrent
62135-626-1262135062612120 TABLET, FILM COATED in 1 BOTTLE (62135-626-12) 2020-01-010000-00-00NoNoCurrent
62135-626-206213506262020 TABLET, FILM COATED in 1 BOTTLE (62135-626-20) 1984-09-110000-00-00NoNoCurrent
62135-626-2362135062623210 TABLET, FILM COATED in 1 BOTTLE (62135-626-23) 2020-01-010000-00-00NoNoCurrent
62135-626-286213506262828 TABLET, FILM COATED in 1 BOTTLE (62135-626-28) 2020-01-010000-00-00NoNoCurrent
62135-626-3162135062631300 TABLET, FILM COATED in 1 BOTTLE (62135-626-31) 2020-01-010000-00-00NoNoCurrent
62135-626-4062135062640400 TABLET, FILM COATED in 1 BOTTLE (62135-626-40) 2020-01-010000-00-00NoNoCurrent
62135-626-506213506265050 TABLET, FILM COATED in 1 BOTTLE (62135-626-50) 1984-09-110000-00-00NoNoCurrent
62135-626-96621350626962000 TABLET, FILM COATED in 1 BOTTLE (62135-626-96) 1984-09-110000-00-00NoNoCurrent