Doxycycline Hyclate

Product NDC
42582-216
11-digit product format
425820216
Labeler code
42582
Product ID
42582-216_ec2b635d-3b4e-4573-8939-91b40838639a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bi-Coastal Pharma International, LLC
Application
ANDA209402
Marketing category
ANDA
Marketing start
2020-05-28
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
42582-216-052023-01-30C16284748780-1f386c649-f700-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES, USP
42582-216-182023-01-30C16284748780-1f386c649-f700-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-216-05Doxycycline Hyclate50 in 1 BOTTLECAPSULE503
42582-216-18Doxycycline Hyclate500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42582-216-05EA - Each42582-21654e14644-941e-4161-bfb3-6289a339d57d12020-09-14
42582-216-18EA - Each42582-216ec0a7c02-bcd1-47e8-bcc7-2b1e5d1f80c212021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-216DOXYCYCLINE HYCLATE CAPSULE [BI-COASTAL PHARMA INTERNATIONAL, LLC]3Legacy NDC, 2 package rows20210327_1f8f275a-0ea8-4618-a078-ad450d2a434c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN1f8f275a-0ea8-4618-a078-ad450d2a434c3
1649988doxycycline hyclate 100 MG Oral CapsuleSCD1f8f275a-0ea8-4618-a078-ad450d2a434c3
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY1f8f275a-0ea8-4618-a078-ad450d2a434c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42582-216-054258202160550 CAPSULE in 1 BOTTLE (42582-216-05) 50 capsule2020-05-280000-00-00NoNoCurrent
42582-216-1842582021618100 CAPSULE in 1 BOTTLE (42582-216-18) 100 capsule2020-05-280000-00-00NoNoCurrent