Nicotine

Product NDC
49035-194
11-digit product format
490350194
Labeler code
49035
Product ID
49035-194_085e5042-be1f-49ea-88a8-804fc969824f
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Wal-Mart Stores Inc
Application
NDA020165
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-10-19
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
Brand name suffix
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, 198031

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-194-012021-12-16C16284748780-1ba0f9c33-386a-a910-e053-dadaa90a0b85Drug Facts
49035-194-022021-12-16C16284748780-1ba0f9c33-386a-a910-e053-dadaa90a0b85Drug Facts
49035-194-012021-01-29C16284748780-1ba0f9c33-386a-a910-e053-dadaa90a0b85Drug Facts
49035-194-022021-01-29C16284748780-1ba0f9c33-386a-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-194-01Nicotinetransdermal system7 in 1 CARTONPATCH, EXTENDED RELEASE715
49035-194-01Nicotinetransdermal system24 h in 1 PATCHPATCH, EXTENDED RELEASE2415
49035-194-02Nicotinetransdermal system14 in 1 CARTONPATCH, EXTENDED RELEASE1415
49035-194-02Nicotinetransdermal system24 h in 1 PATCHPATCH, EXTENDED RELEASE2415

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-194NICOTINE TRANSDERMAL SYSTEM (NICOTINE) PATCH, EXTENDED RELEASE [WAL-MART STORES INC]14Current NDC, Legacy NDC, 4 package rows20241220_aefd30c4-35d5-425e-855c-327a7c436188.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNaefd30c4-35d5-425e-855c-327a7c43618815
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNaefd30c4-35d5-425e-855c-327a7c43618815
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNaefd30c4-35d5-425e-855c-327a7c43618815
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDaefd30c4-35d5-425e-855c-327a7c43618815
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDaefd30c4-35d5-425e-855c-327a7c43618815
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDaefd30c4-35d5-425e-855c-327a7c43618815
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198029nicotine 14 MG/Day 24HR Transdermal SystemSYaefd30c4-35d5-425e-855c-327a7c43618815
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198030nicotine 21 MG/Day 24HR Transdermal SystemSYaefd30c4-35d5-425e-855c-327a7c43618815
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYaefd30c4-35d5-425e-855c-327a7c43618815
198031nicotine 7 MG/Day 24HR Transdermal SystemSYaefd30c4-35d5-425e-855c-327a7c43618815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-194-01490350194017 PATCH in 1 CARTON (49035-194-01) / 24 h in 1 PATCH7 patch2010-10-190000-00-00NoNoCurrent
49035-194-024903501940214 PATCH in 1 CARTON (49035-194-02) / 24 h in 1 PATCH14 patch2010-10-190000-00-00NoNoCurrent