Doxycycline Monohydrate

Product NDC
53002-0671
11-digit product format
530020671
Labeler code
53002
Product ID
53002-0671_f7d2ac99-2ff1-4ffa-996e-230b953287b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
NDA050641
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2005-02-07
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0671-0Doxycycline Monohydrate100 in 1 BOTTLECAPSULE1001
53002-0671-1Doxycycline Monohydrate2 in 1 BOTTLECAPSULE21
53002-0671-2Doxycycline Monohydrate10 in 1 BOTTLECAPSULE101
53002-0671-3Doxycycline Monohydrate14 in 1 BOTTLECAPSULE141
53002-0671-4Doxycycline Monohydrate20 in 1 BOTTLECAPSULE201
53002-0671-5Doxycycline Monohydrate28 in 1 BOTTLECAPSULE281
53002-0671-6Doxycycline Monohydrate30 in 1 BOTTLECAPSULE301
53002-0671-7Doxycycline Monohydrate40 in 1 BOTTLECAPSULE401
53002-0671-9Doxycycline Monohydrate60 in 1 BOTTLECAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0671DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 9 package rows20201225_8ced6ac0-22f2-42d2-bced-4a97da5507a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN8ced6ac0-22f2-42d2-bced-4a97da5507a01
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD8ced6ac0-22f2-42d2-bced-4a97da5507a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0671-053002067100100 CAPSULE in 1 BOTTLE (53002-0671-0) 100 capsule2019-01-010000-00-00NoNoCurrent
53002-0671-1530020671012 CAPSULE in 1 BOTTLE (53002-0671-1) 2 capsule2019-01-010000-00-00NoNoCurrent
53002-0671-25300206710210 CAPSULE in 1 BOTTLE (53002-0671-2) 10 capsule2019-01-010000-00-00NoNoCurrent
53002-0671-35300206710314 CAPSULE in 1 BOTTLE (53002-0671-3) 14 capsule2019-01-010000-00-00NoNoCurrent
53002-0671-45300206710420 CAPSULE in 1 BOTTLE (53002-0671-4) 20 capsule2019-01-010000-00-00NoNoCurrent
53002-0671-55300206710528 CAPSULE in 1 BOTTLE (53002-0671-5) 28 capsule2019-01-010000-00-00NoNoCurrent
53002-0671-65300206710630 CAPSULE in 1 BOTTLE (53002-0671-6) 30 capsule2019-01-010000-00-00NoNoCurrent
53002-0671-75300206710740 CAPSULE in 1 BOTTLE (53002-0671-7) 40 capsule2019-01-010000-00-00NoNoCurrent
53002-0671-95300206710960 CAPSULE in 1 BOTTLE (53002-0671-9) 60 capsule2019-01-010000-00-00NoNoCurrent