FDA.reportPublic FDA data

Nicotine Transdermal System

Product NDC
0363-1244
11-digit product format
003631244
Labeler code
0363
Product ID
0363-1244_312d989c-79f6-8f42-e063-6294a90aa812
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Walgreens
Application
ANDA074612
Marketing category
ANDA
Marketing start
2024-09-30
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074612-001NICOTINENICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20
A074612-002NICOTINENICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28
A074612-003NICOTINENICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-208072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine Transdermal System
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE14 mg/24h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198029Internal RxNorm lookup
198030Internal RxNorm lookup
198031Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5aadb95f-428c-b637-01f4-50d5866ced0cAvailable on FDA.report

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
0363-1244-01Nicotine Transdermal System14 in 1 CARTONPATCH, EXTENDED RELEASE147
0363-1244-01Nicotine Transdermal System1 h in 1 POUCHPATCH, EXTENDED RELEASE17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1244NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [WALGREENS]7Current NDC, Legacy NDC, 2 package rows20250327_5aadb95f-428c-b637-01f4-50d5866ced0c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMIngenus Pharmaceuticals, LLC0c25e8b8-7202-459b-85ac-0d757f344b342026-05-20WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAmerisourceBergen Drug Corporation8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e2026-03-31WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMQuitine LLCe4761ed6-509b-4e43-88e0-b0229d24859a2026-03-30WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMH-E-Bda35e19d-b0aa-8a5f-140e-7601bd2027fe2026-03-06WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMTopco Associates LLCa631d31d-38e6-1772-8b6d-57672b785d982026-03-06WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
NicotineNICOTINEMeijer, Inc.78b85047-b412-44fa-91e1-a1c891d478762026-01-22WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAveva Drug Delivery Systems, Inc.55442645-fa9b-4a9b-81e2-345ad062a1242025-11-18WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
MedlineNICOTINEMedline Industries, LPe11a4b7e-6f1f-24db-e053-2a95a90a0d092025-11-04WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAveva Drug Delivery Systems Inc.7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe2025-07-30WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
NicotineNICOTINEStrategic Sourcing Services LLCa08022ff-e412-47f9-8132-318f55528c5c2025-07-30WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINEEXELAN PHARMACEUTICALS, INC.5aeb4f5c-7cc4-4532-b76e-53bdee8e72202025-06-01WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
NicotineNICOTINEA-S Medication Solutions13aa171e-7425-47fc-b618-7759840f06182025-05-30WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMWalgreens5aadb95f-428c-b637-01f4-50d5866ced0c2025-03-25WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
ndc (product): 0363-1244
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMBluePoint Laboratoriesa8a769ce-e41a-696f-e053-2a95a90a6b182025-03-25WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMCardinal Healthc4cc8321-807f-258f-71f5-e993f633f9e32024-11-18WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
foster and thrive STEP 3NICOTINE TRANSDERMAL SYSTEMStrategic Sourcing Services LLCd992645a-f185-48be-887a-e89ab5fcf0392024-06-11WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612
NicotineNICOTINERugby Laboratories2dd4cbda-5c46-4655-b69d-21b7d2e912cf2024-06-05WarningsExact identifier
application applno (ANDA): 074612
application number: ANDA074612

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN5aadb95f-428c-b637-01f4-50d5866ced0c7
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN5aadb95f-428c-b637-01f4-50d5866ced0c7
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN5aadb95f-428c-b637-01f4-50d5866ced0c7
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD5aadb95f-428c-b637-01f4-50d5866ced0c7
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD5aadb95f-428c-b637-01f4-50d5866ced0c7
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD5aadb95f-428c-b637-01f4-50d5866ced0c7
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198029nicotine 14 MG/Day 24HR Transdermal SystemSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198030nicotine 21 MG/Day 24HR Transdermal SystemSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY5aadb95f-428c-b637-01f4-50d5866ced0c7
198031nicotine 7 MG/Day 24HR Transdermal SystemSY5aadb95f-428c-b637-01f4-50d5866ced0c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1244-010036312440114 POUCH in 1 CARTON (0363-1244-01) / 1 h in 1 POUCH14 pouch2024-09-300000-00-00NoNoCurrent