doxycycline hyclate

Product NDC
68180-654
11-digit product format
681800654
Labeler code
68180
Product ID
68180-654_17750379-d852-4148-be6f-24a101886bf1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxyclycline hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA208818
Marketing category
ANDA
Marketing start
2017-10-30
Substance
DOXYCYCLINE HYCLATE
Active strength
150 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 HYCLATE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649425, 1650446

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-654-06doxycycline hyclate30 in 1 BOTTLETABLET, COATED3016
68180-654-07doxycycline hyclate60 in 1 BOTTLETABLET, COATED6016
68180-654-09doxycycline hyclate90 in 1 BOTTLETABLET, COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-654-07EA - Each68180-6545fb89bfc-c6d8-4bd3-8989-9375124353ef12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-654DOXYCYCLINE HYCLATE (DOXYCLYCLINE HYCLATE) TABLET, COATED [LUPIN PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 3 package rows20250507_f234f419-42da-4a6d-82c6-92106cd77c67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650446doxycycline hyclate 150 MG Oral TabletPSNf234f419-42da-4a6d-82c6-92106cd77c6716
1649425doxycycline hyclate 75 MG Oral TabletPSNf234f419-42da-4a6d-82c6-92106cd77c6716
1650446doxycycline hyclate 150 MG Oral TabletSCDf234f419-42da-4a6d-82c6-92106cd77c6716
1649425doxycycline hyclate 75 MG Oral TabletSCDf234f419-42da-4a6d-82c6-92106cd77c6716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-654-066818006540630 TABLET, COATED in 1 BOTTLE (68180-654-06) 2017-10-300000-00-00NoNoCurrent
68180-654-076818006540760 TABLET, COATED in 1 BOTTLE (68180-654-07) 2017-10-300000-00-00NoNoCurrent
68180-654-096818006540990 TABLET, COATED in 1 BOTTLE (68180-654-09) 2017-10-300000-00-00NoNoCurrent