DOXYCYCLINE MONOHYDRATE

Product NDC
61919-624
11-digit product format
619190624
Labeler code
61919
Product ID
61919-624_4c4a0016-0fb6-1dc9-e063-6294a90a9541
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE MONOHYDRATE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA205115
Marketing category
ANDA
Marketing start
2019-04-05
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOXYCYCLINE MONOHYDRATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN12000U13O
Rxcui1649990

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
61919-624-142025-01-30C16284748780-12cef2736-6755-d83d-e063-dadaa90ab31fDOXYCYCLINE MONOHYDRATE 100mg 20CAPS
61919-624-202025-01-30C16284748780-12cef2736-6755-d83d-e063-dadaa90ab31fDOXYCYCLINE MONOHYDRATE 100mg 20CAPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-624-14DOXYCYCLINE MONOHYDRATE14 in 1 BOTTLECAPSULE145
61919-624-20DOXYCYCLINE MONOHYDRATE20 in 1 BOTTLECAPSULE205
61919-624-30DOXYCYCLINE MONOHYDRATE30 in 1 BOTTLECAPSULE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-624-14EA - Each61919-624fae4f49d-15e8-449c-b82f-7d7e400d9b0c12019-11-12
61919-624-20EA - Each61919-624bf95c894-5742-46e1-998b-8d7dbb29344112019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-624DOXYCYCLINE CAPSULE DOXYCYCLINE MONOHYDRATE CAPSULE [DIRECT RX]4Current NDC, Legacy NDC, 3 package rows20230113_31512ece-cb16-2a9a-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN31512ece-cb16-2a9a-e054-00144ff88e885
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD31512ece-cb16-2a9a-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-624-146191906241414 CAPSULE in 1 BOTTLE (61919-624-14) 14 capsule2019-04-050000-00-00NoNoCurrent
61919-624-206191906242020 CAPSULE in 1 BOTTLE (61919-624-20) 20 capsule2019-04-050000-00-00NoNoCurrent
61919-624-306191906243030 CAPSULE in 1 BOTTLE (61919-624-30) 30 capsule2019-04-05NoNoHistorical