FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
21695-044
11-digit product format
216950044
Labeler code
21695
Product ID
21695-044_d583b8b9-e5c7-45d6-8fc1-d51f51a16181
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA062396
Marketing category
ANDA
Marketing start
1984-11-07
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-044-062019-09-24C16284748780-1934fe258-4914-48b1-e053-8cdaa90a720aDoxycycline Hyclate
21695-044-142019-09-24C16284748780-1934fe258-4914-48b1-e053-8cdaa90a720aDoxycycline Hyclate
21695-044-202019-09-24C16284748780-1934fe258-4914-48b1-e053-8cdaa90a720aDoxycycline Hyclate
21695-044-282019-09-24C16284748780-1934fe258-4914-48b1-e053-8cdaa90a720aDoxycycline Hyclate
21695-044-302019-09-24C16284748780-1934fe258-4914-48b1-e053-8cdaa90a720aDoxycycline Hyclate
21695-044-402019-09-24C16284748780-1934fe258-4914-48b1-e053-8cdaa90a720aDoxycycline Hyclate
21695-044-422019-09-24C16284748780-1934fe258-4914-48b1-e053-8cdaa90a720aDoxycycline Hyclate
21695-044-902019-09-24C16284748780-1934fe258-4914-48b1-e053-8cdaa90a720aDoxycycline Hyclate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-044-06Doxycycline Hyclate6 in 1 BOTTLE, PLASTICCAPSULE61
21695-044-14Doxycycline Hyclate14 in 1 BOX, UNIT-DOSECAPSULE141
21695-044-20Doxycycline Hyclate20 in 1 BOTTLE, PLASTICCAPSULE201
21695-044-28Doxycycline Hyclate28 in 1 BOTTLE, PLASTICCAPSULE281
21695-044-30Doxycycline Hyclate30 in 1 BOTTLE, PLASTICCAPSULE301
21695-044-40Doxycycline Hyclate40 in 1 BOTTLE, PLASTICCAPSULE401
21695-044-42Doxycycline Hyclate42 in 1 BOTTLE, PLASTICCAPSULE421
21695-044-90Doxycycline Hyclate90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-044-06EA - Each21695-04403327f2b-e396-4863-bcc0-096305075fcd12012-07-24
21695-044-14EA - Each21695-044e7ba9987-867f-4753-8061-2a86a4e018ff12012-07-24
21695-044-20EA - Each21695-0448d6aaeb6-e5fd-4951-b99b-2ac7b27d5f6d12012-07-24
21695-044-28EA - Each21695-0444848a3e1-9df5-416c-9d6f-a5bc8395892912012-07-24
21695-044-30EA - Each21695-0441275bc1d-be73-4231-9c88-4a9686f3860412012-07-24
21695-044-40EA - Each21695-044b5510b0d-b4da-4957-8b12-ede6a13f76ae12012-07-24
21695-044-42EA - Each21695-044d04ad26a-eef1-45c2-8d2c-6cfb7274d08512012-07-24
21695-044-90EA - Each21695-044677e89aa-9949-4d13-b7d5-4d91a72053b512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-044DOXYCYCLINE HYCLATE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 8 package rows20101119_d583b8b9-e5c7-45d6-8fc1-d51f51a16181.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNd583b8b9-e5c7-45d6-8fc1-d51f51a161811
1649988doxycycline hyclate 100 MG Oral CapsuleSCDd583b8b9-e5c7-45d6-8fc1-d51f51a161811
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYd583b8b9-e5c7-45d6-8fc1-d51f51a161811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-044-06216950044066 in 1 BOTTLE, PLASTICHistorical
21695-044-142169500441414 in 1 BOX, UNIT-DOSEHistorical
21695-044-202169500442020 in 1 BOTTLE, PLASTICHistorical
21695-044-282169500442828 in 1 BOTTLE, PLASTICHistorical
21695-044-302169500443030 in 1 BOTTLE, PLASTICHistorical
21695-044-402169500444040 in 1 BOTTLE, PLASTICHistorical
21695-044-422169500444242 in 1 BOTTLE, PLASTICHistorical
21695-044-902169500449090 in 1 BOTTLE, PLASTICHistorical