FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
68071-3252
11-digit product format
680713252
Labeler code
68071
Product ID
68071-3252_bbf19976-8c32-9daf-e053-2a95a90a612b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA062500
Marketing category
ANDA
Marketing start
1984-09-11
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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
68071-3252-12023-01-30C16284748780-19d75b9d0-07f3-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
68071-3252-22023-01-30C16284748780-19d75b9d0-07f3-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
68071-3252-32023-01-30C16284748780-19d75b9d0-07f3-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
68071-3252-42023-01-30C16284748780-19d75b9d0-07f3-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
68071-3252-12020-09-17C16284748780-19d75b9d0-07f3-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
68071-3252-32020-09-17C16284748780-19d75b9d0-07f3-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
68071-3252-42020-09-17C16284748780-19d75b9d0-07f3-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
68071-3252-12020-01-31C16284748780-19d75b9d0-07f3-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
68071-3252-32020-01-31C16284748780-19d75b9d0-07f3-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP
68071-3252-42020-01-31C16284748780-19d75b9d0-07f3-f424-e053-dadaa90a57ceDoxycycline Hyclate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3252-1Doxycycline Hyclate10 in 1 BOTTLECAPSULE103
68071-3252-2Doxycycline Hyclate20 in 1 BOTTLECAPSULE203
68071-3252-3Doxycycline Hyclate30 in 1 BOTTLECAPSULE303
68071-3252-4Doxycycline Hyclate14 in 1 BOTTLECAPSULE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3252DOXYCYCLINE HYCLATE CAPSULE [NUCARE PHARMACEUTICALS, INC.]3Legacy NDC, 4 package rows20210223_517646d8-362b-5cf2-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN517646d8-362b-5cf2-e054-00144ff88e883
1649988doxycycline hyclate 100 MG Oral CapsuleSCD517646d8-362b-5cf2-e054-00144ff88e883
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY517646d8-362b-5cf2-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3252-16807132520110 CAPSULE in 1 BOTTLE (68071-3252-1) 10 capsule2017-06-080000-00-00NoNoCurrent
68071-3252-26807132520220 CAPSULE in 1 BOTTLE (68071-3252-2) 20 capsule2017-06-080000-00-00NoNoCurrent
68071-3252-36807132520330 CAPSULE in 1 BOTTLE (68071-3252-3) 30 capsule2017-06-080000-00-00NoNoCurrent
68071-3252-46807132520414 CAPSULE in 1 BOTTLE (68071-3252-4) 14 capsule2017-06-080000-00-00NoNoCurrent