FDA.reportPublic FDA data

doxycycline hyclate

Product NDC
62135-985
11-digit product format
621350985
Labeler code
62135
Product ID
62135-985_40077986-5ebb-f8f0-e063-6394a90ad09f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Chartwell RX LLC
Application
ANDA062500
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
62135-985-01doxycycline hyclate100 in 1 BOTTLECAPSULE10016
62135-985-05doxycycline hyclate500 in 1 BOTTLECAPSULE50016
62135-985-10doxycycline hyclate1000 in 1 BOTTLECAPSULE100016
62135-985-50doxycycline hyclate50 in 1 BOTTLECAPSULE5016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-985-05EA - Each62135-985fcd45a64-61cb-4f0e-88eb-79efd402577c12019-07-02
62135-985-50EA - Each62135-985f9b4c21a-fb0e-4422-bf3f-7fa89aa44f0d12019-07-02

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
62135-985DOXYCYCLINE HYCLATE TABLET, FILM COATED DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE POWDER, FOR SUSPENSION [CHARTWELL RX LLC]15Current NDC, Legacy NDC, 4 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
1649988doxycycline hyclate 100 MG Oral CapsulePSN1dd7a94e-bf29-4f07-9476-ac8d1f9ab5658
1649988doxycycline hyclate 100 MG Oral CapsuleSCD1dd7a94e-bf29-4f07-9476-ac8d1f9ab5658
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY1dd7a94e-bf29-4f07-9476-ac8d1f9ab5658
1649988doxycycline hyclate 100 MG Oral CapsulePSN4164f6b7-5ebd-4f5f-a536-9a37b2e0562c7
1649988doxycycline hyclate 100 MG Oral CapsulePSN6f530f28-8c10-41dc-818f-1aef2306bde57
1649988doxycycline hyclate 100 MG Oral CapsuleSCD4164f6b7-5ebd-4f5f-a536-9a37b2e0562c7
1649988doxycycline hyclate 100 MG Oral CapsuleSCD6f530f28-8c10-41dc-818f-1aef2306bde57
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY4164f6b7-5ebd-4f5f-a536-9a37b2e0562c7
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY6f530f28-8c10-41dc-818f-1aef2306bde57
1649988doxycycline hyclate 100 MG Oral CapsulePSNa5f02688-cbba-4d9b-e053-2995a90ad1ba4
1649988doxycycline hyclate 100 MG Oral CapsulePSNf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline hyclate 100 MG Oral CapsulePSNa2161675-505c-3d65-e053-2995a90aa6444
1650143doxycycline hyclate 100 MG Oral TabletPSNf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline hyclate 100 MG Oral CapsuleSCDa2161675-505c-3d65-e053-2995a90aa6444
1649988doxycycline hyclate 100 MG Oral CapsuleSCDa5f02688-cbba-4d9b-e053-2995a90ad1ba4
1650143doxycycline hyclate 100 MG Oral TabletSCDf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYa2161675-505c-3d65-e053-2995a90aa6444
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYa5f02688-cbba-4d9b-e053-2995a90ad1ba4
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline hyclate 100 MG Oral CapsulePSNa5571acf-3284-4559-8cc0-b4856ac6d94d3
1649988doxycycline hyclate 100 MG Oral CapsuleSCDa5571acf-3284-4559-8cc0-b4856ac6d94d3
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYa5571acf-3284-4559-8cc0-b4856ac6d94d3
1649988doxycycline hyclate 100 MG Oral CapsulePSN2993ac3d-0ec4-4230-858e-9fd00063cf572
1649988doxycycline hyclate 100 MG Oral CapsuleSCD2993ac3d-0ec4-4230-858e-9fd00063cf572
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY2993ac3d-0ec4-4230-858e-9fd00063cf572
1649988doxycycline hyclate 100 MG Oral CapsulePSNb429a1e9-5bbb-8b27-e053-2a95a90a089f1
1649988doxycycline hyclate 100 MG Oral CapsulePSN50617adc-8528-414d-bb6c-78887d4049831
1649988doxycycline hyclate 100 MG Oral CapsuleSCDb429a1e9-5bbb-8b27-e053-2a95a90a089f1
1649988doxycycline hyclate 100 MG Oral CapsuleSCD50617adc-8528-414d-bb6c-78887d4049831
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYb429a1e9-5bbb-8b27-e053-2a95a90a089f1
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY50617adc-8528-414d-bb6c-78887d4049831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-985-0162135098501100 CAPSULE in 1 BOTTLE (62135-985-01) 100 capsule2020-09-010000-00-00NoNoCurrent
62135-985-0562135098505500 CAPSULE in 1 BOTTLE (62135-985-05) 500 capsule1984-09-110000-00-00NoNoCurrent
62135-985-10621350985101000 CAPSULE in 1 BOTTLE (62135-985-10) 1000 capsule2020-09-010000-00-00NoNoCurrent
62135-985-506213509855050 CAPSULE in 1 BOTTLE (62135-985-50) 50 capsule1984-09-110000-00-00NoNoCurrent