FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
51655-478
11-digit product format
516550478
Labeler code
51655
Product ID
51655-478_49ee7977-7bf1-f52f-e063-6294a90a579d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA062396
Marketing category
ANDA
Marketing start
2023-01-05
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-478-202026-01-29C16284748780-149896155-b6b6-586f-e063-e6dba90add90Doxycycline Hyclate Capsules - Hikma
51655-478-292026-01-29C16284748780-149896155-b6b6-586f-e063-e6dba90add90Doxycycline Hyclate Capsules - Hikma
51655-478-532026-01-29C16284748780-149896155-b6b6-586f-e063-e6dba90add90Doxycycline Hyclate Capsules - Hikma
51655-478-842026-01-29C16284748780-149896155-b6b6-586f-e063-e6dba90add90Doxycycline Hyclate Capsules - Hikma

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-478-20Doxycycline Hyclate20 in 1 BOTTLE, PLASTICCAPSULE203
51655-478-29Doxycycline Hyclate28 in 1 BOTTLE, PLASTICCAPSULE283
51655-478-53Doxycycline Hyclate10 in 1 BOTTLE, PLASTICCAPSULE103
51655-478-84Doxycycline Hyclate14 in 1 BOTTLE, PLASTICCAPSULE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-478DOXYCYCLINE HYCLATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 4 package rows20230701_f309ccbb-b68a-3190-e053-2995a90a0ad4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNf309ccbb-b68a-3190-e053-2995a90a0ad43
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf309ccbb-b68a-3190-e053-2995a90a0ad43
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf309ccbb-b68a-3190-e053-2995a90a0ad43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-478-205165504782020 CAPSULE in 1 BOTTLE, PLASTIC (51655-478-20) 20 capsule2023-01-05NoNoCurrent
51655-478-295165504782928 CAPSULE in 1 BOTTLE, PLASTIC (51655-478-29) 28 capsule2023-01-19NoNoCurrent
51655-478-535165504785310 CAPSULE in 1 BOTTLE, PLASTIC (51655-478-53) 10 capsule2023-01-11NoNoCurrent
51655-478-845165504788414 CAPSULE in 1 BOTTLE, PLASTIC (51655-478-84) 14 capsule2023-06-02NoNoCurrent