Doxycycline Hyclate

Product NDC
80425-0211
11-digit product format
804250211
Labeler code
80425
Product ID
80425-0211_2a99c981-daf7-71e5-e063-6294a90a5c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA062676
Marketing category
ANDA
Marketing start
2022-11-04
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 Hyclate
Listing expiration
2026-12-31

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
80425-0211-1Doxycycline Hyclate20 in 1 BOTTLECAPSULE206
80425-0211-2Doxycycline Hyclate10 in 1 BOTTLECAPSULE106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0211-1EA - Each80425-02115386f4e5-9990-4191-93dd-f66691f0e8e012023-04-07
80425-0211-2EA - Each80425-0211c91c1609-8501-4011-9c3b-6d295931176512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0211DOXYCYCLINE HYCLATE CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 2 package rows20250101_ecab47ea-d7b9-515d-e053-2995a90adc46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNecab47ea-d7b9-515d-e053-2995a90adc466
1649988doxycycline hyclate 100 MG Oral CapsuleSCDecab47ea-d7b9-515d-e053-2995a90adc466
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYecab47ea-d7b9-515d-e053-2995a90adc466

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0211-18042502110120 CAPSULE in 1 BOTTLE (80425-0211-1) 20 capsule2023-11-04NoNoCurrent
80425-0211-28042502110210 CAPSULE in 1 BOTTLE (80425-0211-2) 10 capsule2023-11-04NoNoCurrent