FDA.reportPublic FDA data

Nicotine Transdermal System

Product NDC
37808-461
11-digit product format
378080461
Labeler code
37808
Product ID
37808-461_4c5ae925-c022-9e90-e063-6394a90a50fa
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
H-E-B
Application
ANDA074612
Marketing category
ANDA
Marketing start
2024-06-25
Substance
NICOTINE
Active strength
21 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Transdermal System
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE21 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui198029, 198030

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
37808-461-01Nicotine Transdermal System14 in 1 CARTONPATCH, EXTENDED RELEASE149
37808-461-01Nicotine Transdermal System1 h in 1 POUCHPATCH, EXTENDED RELEASE19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-461NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [H-E-B]8Current NDC, Legacy NDC, 2 package rows20240625_da35e19d-b0aa-8a5f-140e-7601bd2027fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNda35e19d-b0aa-8a5f-140e-7601bd2027fe9
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNda35e19d-b0aa-8a5f-140e-7601bd2027fe9
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDda35e19d-b0aa-8a5f-140e-7601bd2027fe9
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDda35e19d-b0aa-8a5f-140e-7601bd2027fe9
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYda35e19d-b0aa-8a5f-140e-7601bd2027fe9
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYda35e19d-b0aa-8a5f-140e-7601bd2027fe9
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYda35e19d-b0aa-8a5f-140e-7601bd2027fe9
198029nicotine 14 MG/Day 24HR Transdermal SystemSYda35e19d-b0aa-8a5f-140e-7601bd2027fe9
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYda35e19d-b0aa-8a5f-140e-7601bd2027fe9
198030nicotine 21 MG/Day 24HR Transdermal SystemSYda35e19d-b0aa-8a5f-140e-7601bd2027fe9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-461-013780804610114 POUCH in 1 CARTON (37808-461-01) / 1 h in 1 POUCH14 pouch2024-06-250000-00-00NoNoCurrent