FDA.reportPublic FDA data

Doxycycline hyclate

Product NDC
85766-033
11-digit product format
857660033
Labeler code
85766
Product ID
85766-033_4a2b43cc-b0c5-0c95-e063-6394a90a0031
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA207774
Marketing category
ANDA
Marketing start
2022-01-10
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline hyclate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649988

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
85766-033-00Doxycycline hyclate1000 in 1 BOTTLECAPSULE10002
85766-033-01Doxycycline hyclate100 in 1 BOTTLECAPSULE1002
85766-033-05Doxycycline hyclate500 in 1 BOTTLECAPSULE5002
85766-033-10Doxycycline hyclate10 in 1 BOTTLECAPSULE102
85766-033-14Doxycycline hyclate14 in 1 BOTTLECAPSULE142
85766-033-20Doxycycline hyclate20 in 1 BOTTLECAPSULE202
85766-033-28Doxycycline hyclate28 in 1 BOTTLECAPSULE282
85766-033-30Doxycycline hyclate30 in 1 BOTTLECAPSULE302
85766-033-50Doxycycline hyclate50 in 1 BOTTLECAPSULE502
85766-033-60Doxycycline hyclate60 in 1 BOTTLECAPSULE602
85766-033-90Doxycycline hyclate90 in 1 BOTTLECAPSULE902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN45c4b584-b7e2-4e91-a93d-aff14feb606f2
1649988doxycycline hyclate 100 MG Oral CapsuleSCD45c4b584-b7e2-4e91-a93d-aff14feb606f2
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY45c4b584-b7e2-4e91-a93d-aff14feb606f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-033-00857660033001000 CAPSULE in 1 BOTTLE (85766-033-00) 1000 capsule2025-08-17NoNoCurrent
85766-033-0185766003301100 CAPSULE in 1 BOTTLE (85766-033-01) 100 capsule2025-08-17NoNoCurrent
85766-033-0585766003305500 CAPSULE in 1 BOTTLE (85766-033-05) 500 capsule2025-08-17NoNoCurrent
85766-033-108576600331010 CAPSULE in 1 BOTTLE (85766-033-10) 10 capsule2025-08-17NoNoCurrent
85766-033-148576600331414 CAPSULE in 1 BOTTLE (85766-033-14) 14 capsule2025-08-17NoNoCurrent
85766-033-208576600332020 CAPSULE in 1 BOTTLE (85766-033-20) 20 capsule2025-08-17NoNoCurrent
85766-033-288576600332828 CAPSULE in 1 BOTTLE (85766-033-28) 28 capsule2025-08-17NoNoCurrent
85766-033-308576600333030 CAPSULE in 1 BOTTLE (85766-033-30) 30 capsule2025-08-17NoNoCurrent
85766-033-508576600335050 CAPSULE in 1 BOTTLE (85766-033-50) 50 capsule2025-08-17NoNoCurrent
85766-033-608576600336060 CAPSULE in 1 BOTTLE (85766-033-60) 60 capsule2025-08-17NoNoCurrent
85766-033-908576600339090 CAPSULE in 1 BOTTLE (85766-033-90) 90 capsule2025-08-17NoNoCurrent