Doxycycline

Product NDC
42192-501
11-digit product format
421920501
Labeler code
42192
Product ID
42192-501_3b12eb84-4431-551b-e063-6294a90acd6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
Application
ANDA210664
Marketing category
ANDA
Marketing start
2020-08-21
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1650143

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
42192-501-05Doxycycline500 in 1 BOTTLETABLET, COATED5007
42192-501-50Doxycycline50 in 1 BOTTLETABLET, COATED507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-501DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [ACELLA PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 2 package rows20250321_3fb9f5ad-90a2-4858-bc34-f800d8b2fa90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN3fb9f5ad-90a2-4858-bc34-f800d8b2fa907
1650143doxycycline hyclate 100 MG Oral TabletSCD3fb9f5ad-90a2-4858-bc34-f800d8b2fa907
1650143doxycycline hyclate 100 MG Oral TabletPSN2c29f716-bdb0-437d-92a4-d856b87db9765
1650143doxycycline hyclate 100 MG Oral TabletSCD2c29f716-bdb0-437d-92a4-d856b87db9765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42192-501-0542192050105500 TABLET, COATED in 1 BOTTLE (42192-501-05) 2020-08-210000-00-00NoNoCurrent
42192-501-504219205015050 TABLET, COATED in 1 BOTTLE (42192-501-50) 2020-08-210000-00-00NoNoCurrent