Doxycycline hyclate

Product NDC
70518-4150
11-digit product format
705184150
Labeler code
70518
Product ID
70518-4150_47cd0f61-d0a2-7a3c-e063-6394a90a0b0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207774
Marketing category
ANDA
Marketing start
2024-07-29
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
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
70518-4150-0Doxycycline hyclate14 in 1 BOTTLE, PLASTICCAPSULE144
70518-4150-1Doxycycline hyclate56 in 1 BOTTLE, PLASTICCAPSULE564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4150DOXYCYCLINE HYCLATE CAPSULE [REMEDYREPACK INC.]1Current NDC, 2 package rows20240730_df44c686-de34-487a-8741-a0a12993cab2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNdf44c686-de34-487a-8741-a0a12993cab24
1649988doxycycline hyclate 100 MG Oral CapsuleSCDdf44c686-de34-487a-8741-a0a12993cab24
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYdf44c686-de34-487a-8741-a0a12993cab24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4150-07051841500014 CAPSULE in 1 BOTTLE, PLASTIC (70518-4150-0) 14 capsule2024-07-29NoNoCurrent
70518-4150-17051841500156 CAPSULE in 1 BOTTLE, PLASTIC (70518-4150-1) 56 capsule2026-01-07NoNoCurrent