FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
68071-4950
11-digit product format
680714950
Labeler code
68071
Product ID
68071-4950_43e7457d-17b3-32f7-e063-6294a90afee4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA062396
Marketing category
ANDA
Marketing start
1990-09-01
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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4950-42021-02-18C16284748780-1ba0f9c33-1308-a910-e053-dadaa90a0b85Doxycycline Hyclate Capsules - Hikma
68071-4950-42021-01-29C16284748780-1ba0f9c33-1308-a910-e053-dadaa90a0b85Doxycycline Hyclate Capsules - Hikma

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4950-2Doxycycline Hyclate20 in 1 BOTTLECAPSULE206
68071-4950-3Doxycycline Hyclate30 in 1 BOTTLECAPSULE306
68071-4950-4Doxycycline Hyclate14 in 1 BOTTLECAPSULE146
68071-4950-8Doxycycline Hyclate28 in 1 BOTTLECAPSULE286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4950DOXYCYCLINE HYCLATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 4 package rows20240619_8c525e4e-6e1b-4579-e053-2a95a90a43da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN8c525e4e-6e1b-4579-e053-2a95a90a43da6
1649988doxycycline hyclate 100 MG Oral CapsuleSCD8c525e4e-6e1b-4579-e053-2a95a90a43da6
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY8c525e4e-6e1b-4579-e053-2a95a90a43da6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4950-26807149500220 CAPSULE in 1 BOTTLE (68071-4950-2) 20 capsule2019-06-270000-00-00NoNoCurrent
68071-4950-36807149500330 CAPSULE in 1 BOTTLE (68071-4950-3) 30 capsule2025-11-18NoNoCurrent
68071-4950-46807149500414 CAPSULE in 1 BOTTLE (68071-4950-4) 14 capsule2019-06-270000-00-00NoNoCurrent
68071-4950-86807149500828 CAPSULE in 1 BOTTLE (68071-4950-8) 28 capsule2023-06-22NoNoCurrent