FDA.reportPublic FDA data

doxycycline hyclate

Product NDC
72162-2186
11-digit product format
721622186
Labeler code
72162
Product ID
72162-2186_c89b98c9-a72d-4d2c-a9df-b13c754c63e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA062500
Marketing category
ANDA
Marketing start
1984-09-11
Substance
DOXYCYCLINE HYCLATE
Active strength
50 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 HYCLATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649405

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
72162-2186-2doxycycline hyclate50 in 1 BOTTLECAPSULE50103
72162-2186-5doxycycline hyclate500 in 1 BOTTLECAPSULE500103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2186-2EA - Each72162-21861c92d209-4aba-44c0-9de3-31c2eacd22d412024-02-14
72162-2186-5EA - Each72162-21861a23d119-38e7-4233-b6e6-41c4452bed6612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2186DOXYCYCLINE HYCLATE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20240718_0aaa4ff7-7fba-4a40-9b49-82e4da68a48f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649405doxycycline hyclate 50 MG Oral CapsulePSN0aaa4ff7-7fba-4a40-9b49-82e4da68a48f103
1649405doxycycline hyclate 50 MG Oral CapsuleSCD0aaa4ff7-7fba-4a40-9b49-82e4da68a48f103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2186-27216221860250 CAPSULE in 1 BOTTLE (72162-2186-2) 50 capsule1984-09-11NoNoCurrent
72162-2186-572162218605500 CAPSULE in 1 BOTTLE (72162-2186-5) 500 capsule2024-07-16NoNoCurrent