FDA.reportPublic FDA data

Nicotine

Product NDC
63868-735
11-digit product format
638680735
Labeler code
63868
Product ID
63868-735_883afa1b-0596-db0f-b029-26d3d6a7d110
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Chain Drug Marketing Association INC
Application
NDA020076
Marketing category
NDA
Marketing start
2020-10-31
Substance
NICOTINE
Active strength
21 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Brand name suffix
transdermal system step 1
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-735-142024-01-30C16284748780-11030e365-66b6-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-735-14Nicotine transdermal system step 114 in 1 CARTONPATCH, EXTENDED RELEASE146
63868-735-14Nicotine transdermal system step 124 h in 1 PATCHPATCH, EXTENDED RELEASE246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-735-14EA - Each63868-73558bc91d0-ccc7-4536-8078-65de277000e212021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-735NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]6Current NDC, Legacy NDC, 2 package rows20240726_df1348cb-0d15-7e4b-921c-d8764c858e66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNdf1348cb-0d15-7e4b-921c-d8764c858e666
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNdf1348cb-0d15-7e4b-921c-d8764c858e666
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDdf1348cb-0d15-7e4b-921c-d8764c858e666
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDdf1348cb-0d15-7e4b-921c-d8764c858e666
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYdf1348cb-0d15-7e4b-921c-d8764c858e666
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYdf1348cb-0d15-7e4b-921c-d8764c858e666
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYdf1348cb-0d15-7e4b-921c-d8764c858e666
198029nicotine 14 MG/Day 24HR Transdermal SystemSYdf1348cb-0d15-7e4b-921c-d8764c858e666
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYdf1348cb-0d15-7e4b-921c-d8764c858e666
198030nicotine 21 MG/Day 24HR Transdermal SystemSYdf1348cb-0d15-7e4b-921c-d8764c858e666

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-735-146386807351414 PATCH in 1 CARTON (63868-735-14) / 24 h in 1 PATCH14 patch2020-10-310000-00-00NoNoCurrent