Doxycycline

Product NDC
70518-3363
11-digit product format
705183363
Labeler code
70518
Product ID
70518-3363_497365ff-c7cd-6fd6-e063-6294a90a4d50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210664
Marketing category
ANDA
Marketing start
2022-02-10
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
Listing expiration
2027-12-31

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
70518-3363-0Doxycycline14 in 1 BOTTLE, PLASTICTABLET, COATED145
70518-3363-1Doxycycline28 in 1 BOTTLE, PLASTICTABLET, COATED285

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
70518-3363-07051833630014 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3363-0) 2022-02-100000-00-00NoNoCurrent
70518-3363-17051833630128 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3363-1) 2026-01-27NoNoCurrent