FDA.reportPublic FDA data

Nicotine

Product NDC
43598-448
11-digit product format
435980448
Labeler code
43598
Product ID
43598-448_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
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, 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
43598-448-282024-01-30C16284748780-11030e365-641d-111a-e063-dadaa90a10e2Drug Facts
43598-448-702024-01-30C16284748780-11030e365-641d-111a-e063-dadaa90a10e2Drug Facts
43598-448-742024-01-30C16284748780-11030e365-641d-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-448-28Nicotine transdermal system step 128 in 1 CARTONPATCH, EXTENDED RELEASE2811
43598-448-28Nicotine transdermal system step 124 h in 1 PATCHPATCH, EXTENDED RELEASE2411
43598-448-70Nicotine transdermal system step 124 h in 1 PATCHPATCH, EXTENDED RELEASE2411
43598-448-70Nicotine transdermal system step 17 in 1 CARTONPATCH, EXTENDED RELEASE711
43598-448-74Nicotine transdermal system step 124 h in 1 PATCHPATCH, EXTENDED RELEASE2411
43598-448-74Nicotine transdermal system step 114 in 1 CARTONPATCH, EXTENDED RELEASE1411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-448-28EA - Each43598-448c86cd4a5-6444-46cd-873f-f9832e13937212015-06-09
43598-448-70EA - Each43598-448e4d89091-c12a-4ad9-aa48-0846078f336612015-06-09
43598-448-74EA - Each43598-448d8e6f24d-9214-4b58-bb52-e65cc3d6b43e12015-06-09

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
43598-448NICOTINE 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, 6 package rows20240726_3a68eb70-0548-fa6f-8b1c-375e8799f24f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNcfb56e3e-ac5d-4086-a5d3-23080844b3e122
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDcfb56e3e-ac5d-4086-a5d3-23080844b3e122
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYcfb56e3e-ac5d-4086-a5d3-23080844b3e122
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYcfb56e3e-ac5d-4086-a5d3-23080844b3e122
198030nicotine 21 MG/Day 24HR Transdermal SystemSYcfb56e3e-ac5d-4086-a5d3-23080844b3e122
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN44536fb0-dc5d-4c50-8d10-19dd9a0d997819
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
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD44536fb0-dc5d-4c50-8d10-19dd9a0d997819
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY44536fb0-dc5d-4c50-8d10-19dd9a0d997819
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 per 24HR 1 Day Transdermal PatchSY44536fb0-dc5d-4c50-8d10-19dd9a0d997819
198030nicotine 21 MG/Day 24HR Transdermal SystemSY44536fb0-dc5d-4c50-8d10-19dd9a0d997819
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 SystemSCDd51d5224-f5bf-2510-1fa0-c4bb454f816011
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD3a68eb70-0548-fa6f-8b1c-375e8799f24f11
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD3a68eb70-0548-fa6f-8b1c-375e8799f24f11
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
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 PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
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 PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198030nicotine 21 MG/Day 24HR Transdermal SystemSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 21 MG/Day 24HR Transdermal SystemSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
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
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
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
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
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 PatchSYf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
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 per 24HR 1 Day Transdermal PatchSYf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
198030nicotine 21 MG/Day 24HR Transdermal SystemSYde471db4-b332-0490-198d-d3548027287410
198030nicotine 21 MG/Day 24HR Transdermal SystemSYf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-448-284359804482828 PATCH in 1 CARTON (43598-448-28) / 24 h in 1 PATCH28 patch2019-03-310000-00-00NoNoCurrent
43598-448-70435980448707 PATCH in 1 CARTON (43598-448-70) / 24 h in 1 PATCH7 patch2019-03-310000-00-00NoNoCurrent
43598-448-744359804487414 PATCH in 1 CARTON (43598-448-74) / 24 h in 1 PATCH14 patch2019-03-310000-00-00NoNoCurrent