FDA.reportPublic FDA data

Nicotine

Product NDC
43598-447
11-digit product format
435980447
Labeler code
43598
Product ID
43598-447_15710e2c-e365-1726-06de-fb172f976a3b
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
NDA020076
Marketing category
NDA
Marketing start
2015-05-14
Substance
NICOTINE
Active strength
14 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 2
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE14 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
43598-447-702024-01-30C16284748780-11030e365-641d-111a-e063-dadaa90a10e2Drug Facts
43598-447-742024-01-30C16284748780-11030e365-641d-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-447-70Nicotine transdermal system step 27 in 1 CARTONPATCH, EXTENDED RELEASE711
43598-447-70Nicotine transdermal system step 224 h in 1 PATCHPATCH, EXTENDED RELEASE2411
43598-447-74Nicotine transdermal system step 214 in 1 CARTONPATCH, EXTENDED RELEASE1411
43598-447-74Nicotine transdermal system step 224 h in 1 PATCHPATCH, EXTENDED RELEASE2411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-447-70EA - Each43598-4473a33579f-b61f-4cfb-abda-27f0d4ac63c112015-06-09
43598-447-74EA - Each43598-4470fe11eb5-bbe1-49ff-a36f-868187505d0b12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]3
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]3
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]3
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [THE KROGER CO.]2
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [CVS PHARMACY]2
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [WALGREENS COMPANY]2
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [THE KROGER CO.]2
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [CVS PHARMACY]2
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [WALGREENS COMPANY]2
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [THE KROGER CO.]2
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [CVS PHARMACY]2
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [WALGREENS COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-447NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]11Current NDC, Legacy NDC, 4 package rows20240726_3a68eb70-0548-fa6f-8b1c-375e8799f24f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN721a31b6-20b3-4b1f-b019-82849af6ecdd19
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD721a31b6-20b3-4b1f-b019-82849af6ecdd19
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD721a31b6-20b3-4b1f-b019-82849af6ecdd19
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198029nicotine 14 MG/Day 24HR Transdermal SystemSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 21 MG/Day 24HR Transdermal SystemSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN3a68eb70-0548-fa6f-8b1c-375e8799f24f11
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDd51d5224-f5bf-2510-1fa0-c4bb454f816011
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD3a68eb70-0548-fa6f-8b1c-375e8799f24f11
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD3a68eb70-0548-fa6f-8b1c-375e8799f24f11
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDd51d5224-f5bf-2510-1fa0-c4bb454f816011
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDd51d5224-f5bf-2510-1fa0-c4bb454f816011
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 14 MG/Day 24HR Transdermal SystemSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 14 MG/Day 24HR Transdermal SystemSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 21 MG/Day 24HR Transdermal SystemSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198030nicotine 21 MG/Day 24HR Transdermal SystemSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 7 MG/Day 24HR Transdermal SystemSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 7 MG/Day 24HR Transdermal SystemSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNde471db4-b332-0490-198d-d3548027287410
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNde471db4-b332-0490-198d-d3548027287410
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNde471db4-b332-0490-198d-d3548027287410
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDde471db4-b332-0490-198d-d3548027287410
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDde471db4-b332-0490-198d-d3548027287410
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDde471db4-b332-0490-198d-d3548027287410
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198029nicotine 14 MG/Day 24HR Transdermal SystemSYde471db4-b332-0490-198d-d3548027287410
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198030nicotine 21 MG/Day 24HR Transdermal SystemSYde471db4-b332-0490-198d-d3548027287410
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198031nicotine 7 MG/Day 24HR Transdermal SystemSYde471db4-b332-0490-198d-d3548027287410
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN13cdd780-4196-685b-3cab-f9694a3276189
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN13cdd780-4196-685b-3cab-f9694a3276189
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN13cdd780-4196-685b-3cab-f9694a3276189
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD13cdd780-4196-685b-3cab-f9694a3276189
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD13cdd780-4196-685b-3cab-f9694a3276189
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD13cdd780-4196-685b-3cab-f9694a3276189
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY13cdd780-4196-685b-3cab-f9694a3276189
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY13cdd780-4196-685b-3cab-f9694a3276189
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY13cdd780-4196-685b-3cab-f9694a3276189
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY13cdd780-4196-685b-3cab-f9694a3276189
198029nicotine 14 MG/Day 24HR Transdermal SystemSY13cdd780-4196-685b-3cab-f9694a3276189
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY13cdd780-4196-685b-3cab-f9694a3276189
198030nicotine 21 MG/Day 24HR Transdermal SystemSY13cdd780-4196-685b-3cab-f9694a3276189
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY13cdd780-4196-685b-3cab-f9694a3276189
198031nicotine 7 MG/Day 24HR Transdermal SystemSY13cdd780-4196-685b-3cab-f9694a3276189
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNcc51e868-090a-4ba5-8cb2-b69d7479d0688
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN7c83d507-7e8d-496c-bb9d-63abfa25c7a78
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN7c83d507-7e8d-496c-bb9d-63abfa25c7a78
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN7c83d507-7e8d-496c-bb9d-63abfa25c7a78
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD7c83d507-7e8d-496c-bb9d-63abfa25c7a78
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDcc51e868-090a-4ba5-8cb2-b69d7479d0688
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD7c83d507-7e8d-496c-bb9d-63abfa25c7a78
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD7c83d507-7e8d-496c-bb9d-63abfa25c7a78
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY7c83d507-7e8d-496c-bb9d-63abfa25c7a78
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYcc51e868-090a-4ba5-8cb2-b69d7479d0688

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-447-70435980447707 PATCH in 1 CARTON (43598-447-70) / 24 h in 1 PATCH7 patch2019-03-310000-00-00NoNoCurrent
43598-447-744359804477414 PATCH in 1 CARTON (43598-447-74) / 24 h in 1 PATCH14 patch2019-04-050000-00-00NoNoCurrent