FDA.reportPublic FDA data

Nicotine Transdermal System

Product NDC
3215-1202
11-digit product format
032151202
Labeler code
3215
Product ID
3215-1202_3b26fb9e-e895-8cf8-e063-6294a90af3b5
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Aveva Drug Delivery Systems Inc.
Application
ANDA074612
Marketing category
ANDA
Marketing start
2024-06-25
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
7cdad3b0-82d5-400f-a7f5-ac2e9d4478feAvailable 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
3215-1202-07Nicotine Transdermal System24 h in 1 POUCHPATCH241
3215-1202-07Nicotine Transdermal System7 in 1 CARTONPATCH71
3215-1202-14Nicotine Transdermal System14 in 1 CARTONPATCH141
3215-1202-14Nicotine Transdermal System24 h in 1 POUCHPATCH241
3215-1202-28Nicotine Transdermal System24 h in 1 POUCHPATCH241
3215-1202-28Nicotine Transdermal System28 in 1 CARTONPATCH281

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
ndc (product): 3215-1202
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
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 SystemPSN7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198029nicotine 14 MG/Day 24HR Transdermal SystemSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198030nicotine 21 MG/Day 24HR Transdermal SystemSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1
198031nicotine 7 MG/Day 24HR Transdermal SystemSY7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
3215-1202-07032151202077 POUCH in 1 CARTON (3215-1202-07) / 24 h in 1 POUCH7 pouch2024-06-25NoNoCurrent
3215-1202-140321512021414 POUCH in 1 CARTON (3215-1202-14) / 24 h in 1 POUCH14 pouch2024-06-25NoNoCurrent
3215-1202-280321512022828 POUCH in 1 CARTON (3215-1202-28) / 24 h in 1 POUCH28 pouch2024-06-25NoNoCurrent