FDA.reportPublic FDA data

Nicotine Transdermal System

Product NDC
11822-1603
11-digit product format
118221603
Labeler code
11822
Product ID
11822-1603_3637c968-6231-f5ce-58c5-489087c54e36
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System
Dosage form
KIT
Route
TRANSDERMAL
Labeler
Rite Aid Corporation
Application
ANDA074612
Marketing category
ANDA
Marketing start
2021-09-15
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1600-0Nicotine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1414 mg3
11822-1601-0Nicotine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE1414 mg3
11822-1602-0Nicotine Transdermal System1 in 1 POUCHPATCH, EXTENDED RELEASE2821 mg3
11822-1603-1Nicotine Transdermal System1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1603NICOTINE TRANSDERMAL SYSTEM KIT [RITE AID CORPORATION]3Legacy NDC, 4 package rows20230714_a2df73b3-8c06-85fb-c94b-ca8fcd546987.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892244{14 (24 HR nicotine 0.292 MG/HR Transdermal System) / 14 (24 HR nicotine 0.583 MG/HR Transdermal System) / 28 (24 HR nicotine 0.875 MG/HR Transdermal System) } PackGPCKa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNa2df73b3-8c06-85fb-c94b-ca8fcd5469873
892244nicotine 21 MG-14 MG-7 MG 24 HR Transdermal System Kit (56)PSNa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNa2df73b3-8c06-85fb-c94b-ca8fcd5469873
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDa2df73b3-8c06-85fb-c94b-ca8fcd5469873
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDa2df73b3-8c06-85fb-c94b-ca8fcd5469873
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDa2df73b3-8c06-85fb-c94b-ca8fcd5469873
892244{28 (nicotine 21 MG per 24HR 1 Day Transdermal Patch) / 14 (nicotine 14 MG per 24HR 1 Day Transdermal Patch) / 14 (nicotine 7 MG per 24HR 1 Day Transdermal Patch) } PackSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198029nicotine 14 MG/Day 24HR Transdermal SystemSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198030nicotine 21 MG/Day 24HR Transdermal SystemSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873
892244nicotine 7 MG-14 MG-21 MG in 24 HR Transdermal System KitSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873
198031nicotine 7 MG/Day 24HR Transdermal SystemSYa2df73b3-8c06-85fb-c94b-ca8fcd5469873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1600-0118221600001 in 1 POUCHHistorical
11822-1601-0118221601001 in 1 POUCHHistorical
11822-1602-0118221602001 in 1 POUCHHistorical
11822-1603-1118221603011 KIT in 1 CARTON (11822-1603-1) * 1 PATCH, EXTENDED RELEASE in 1 POUCH (11822-1601-0) * 1 PATCH, EXTENDED RELEASE in 1 POUCH (11822-1600-0) * 1 PATCH, EXTENDED RELEASE in 1 POUCH (11822-1602-0) 1 kit2021-09-150000-00-00NoNoCurrent