FDA.reportPublic FDA data

Nexiclon XR

Product NDC
71511-503
11-digit product format
715110503
Labeler code
71511
Product ID
71511-503_4f83c93a-721f-ca2f-e063-6394a90aa789
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rosemont Pharmaceuticals LLC
Application
NDA022500
Marketing category
NDA
Marketing start
2022-03-01
Substance
CLONIDINE
Active strength
.17 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71511-503-30Nexiclon XR30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71511-503-30EA - Each71511-5034f7f6a42-f473-4482-b1ec-5efc6502443a12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71511-503NEXICLON XR (CLONIDINE) TABLET, EXTENDED RELEASE [ATHENA BIOSCIENCE, LLC]1Current NDC, Legacy NDC, 1 package rows20220323_dad35a6f-d57e-f302-e053-2995a90a9efb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
885880cloNIDine 0.17 MG 24HR Extended Release Oral TabletPSNdad35a6f-d57e-f302-e053-2995a90a9efb2
1050338Nexiclon 0.17 MG 24HR Extended Release Oral TabletPSNdad35a6f-d57e-f302-e053-2995a90a9efb2
105033824 HR clonidine 0.17 MG Extended Release Oral Tablet [Nexiclon]SBDdad35a6f-d57e-f302-e053-2995a90a9efb2
88588024 HR clonidine 0.17 MG Extended Release Oral TabletSCDdad35a6f-d57e-f302-e053-2995a90a9efb2
105033824 HR Nexiclon 0.17 MG (equivalent to clonidine HCl 0.2 MG) Extended Release Oral TabletSYdad35a6f-d57e-f302-e053-2995a90a9efb2
105033824 HR Nexiclon 0.17 MG Extended Release Oral TabletSYdad35a6f-d57e-f302-e053-2995a90a9efb2
885880clonidine 0.17 MG (equivalent to clonidine HCl 0.2 MG) 24 HR Extended Release Oral TabletSYdad35a6f-d57e-f302-e053-2995a90a9efb2
1050338Nexiclon XR 0.17 MG 24 HR Extended Release Oral TabletSYdad35a6f-d57e-f302-e053-2995a90a9efb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71511-503-307151105033030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71511-503-30) 2022-03-010000-00-00NoNoCurrent