FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
76420-044
11-digit product format
764200044
Labeler code
76420
Product ID
76420-044_366a8fa7-8681-969e-e063-6294a90a7823
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA062500
Marketing category
ANDA
Marketing start
1984-09-11
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
76420-044-10Doxycycline Hyclate10 in 1 BOTTLECAPSULE103
76420-044-14Doxycycline Hyclate14 in 1 BOTTLECAPSULE143
76420-044-20Doxycycline Hyclate20 in 1 BOTTLECAPSULE203
76420-044-28Doxycycline Hyclate28 in 1 BOTTLECAPSULE283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-044-14EA - Each76420-0443b9bfe83-40e6-4258-846f-a4df1389f5f012022-05-04
76420-044-20EA - Each76420-044f3f8eedc-6923-4f0b-a008-4d4886e2674412022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-044DOXYCYCLINE HYCLATE CAPSULE [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 4 package rows20210616_a5571acf-3284-4559-8cc0-b4856ac6d94d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNa5571acf-3284-4559-8cc0-b4856ac6d94d3
1649988doxycycline hyclate 100 MG Oral CapsuleSCDa5571acf-3284-4559-8cc0-b4856ac6d94d3
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYa5571acf-3284-4559-8cc0-b4856ac6d94d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-044-107642000441010 CAPSULE in 1 BOTTLE (76420-044-10) 10 capsule2020-09-040000-00-00NoNoCurrent
76420-044-147642000441414 CAPSULE in 1 BOTTLE (76420-044-14) 14 capsule2021-06-160000-00-00NoNoCurrent
76420-044-207642000442020 CAPSULE in 1 BOTTLE (76420-044-20) 20 capsule2020-09-040000-00-00NoNoCurrent
76420-044-287642000442828 CAPSULE in 1 BOTTLE (76420-044-28) 28 capsule2025-05-31NoNoCurrent