FDA.reportPublic FDA data

Nicotine Transdermal System Patch

Product NDC
68001-697
11-digit product format
680010697
Labeler code
68001
Product ID
68001-697_4856e41f-dd51-0ee5-e063-6294a90a228f
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System Patch
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
BluePoint Laboratories
Application
NDA020076
Marketing category
NDA
Marketing start
2026-05-11
Substance
NICOTINE
Active strength
7 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 Patch
Brand name suffix
Step 3
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE7 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-697-88Nicotine Transdermal System PatchStep 324 h in 1 PATCHPATCH, EXTENDED RELEASE241
68001-697-88Nicotine Transdermal System PatchStep 37 in 1 CARTONPATCH, EXTENDED RELEASE71
68001-697-90Nicotine Transdermal System PatchStep 324 h in 1 PATCHPATCH, EXTENDED RELEASE241
68001-697-90Nicotine Transdermal System PatchStep 314 in 1 CARTONPATCH, EXTENDED RELEASE141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-697-88EA - Each68001-697b0db622c-1522-4464-88a9-d9e5494273fc12026-05-22
68001-697-90EA - Each68001-6972ccba3cd-1ff8-4525-a478-6f144b2dfad712026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN4856e99a-badc-b957-e063-6294a90a86061
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN4856e99a-badc-b957-e063-6294a90a86061
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN4856e99a-badc-b957-e063-6294a90a86061
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD4856e99a-badc-b957-e063-6294a90a86061
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD4856e99a-badc-b957-e063-6294a90a86061
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD4856e99a-badc-b957-e063-6294a90a86061
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY4856e99a-badc-b957-e063-6294a90a86061
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY4856e99a-badc-b957-e063-6294a90a86061
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY4856e99a-badc-b957-e063-6294a90a86061
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY4856e99a-badc-b957-e063-6294a90a86061
198029nicotine 14 MG/Day 24HR Transdermal SystemSY4856e99a-badc-b957-e063-6294a90a86061
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY4856e99a-badc-b957-e063-6294a90a86061
198030nicotine 21 MG/Day 24HR Transdermal SystemSY4856e99a-badc-b957-e063-6294a90a86061
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY4856e99a-badc-b957-e063-6294a90a86061
198031nicotine 7 MG/Day 24HR Transdermal SystemSY4856e99a-badc-b957-e063-6294a90a86061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-697-88680010697887 PATCH in 1 CARTON (68001-697-88) / 24 h in 1 PATCH7 patch2026-05-11NoNoHistorical
68001-697-906800106979014 PATCH in 1 CARTON (68001-697-90) / 24 h in 1 PATCH14 patch2026-05-11NoNoHistorical