FDA.reportPublic FDA data

Nicotine Transdermal System

Product NDC
60505-7066
11-digit product format
605057066
Labeler code
60505
Product ID
60505-7066_9fabda83-b080-578b-14ba-0d4e55ba9459
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Apotex Corp
Application
ANDA074612
Marketing category
ANDA
Marketing start
1997-10-20
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
21 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60505-7066IInactivated by FDA2026-08-17
excluded packagepackage60505-706660505-7066-0IInactivated by FDA2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20caaa826d4ba7…
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…

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
60505-7066-02026-01-29C16284748780-149896155-c8a5-586f-e063-e6dba90add90Nicotine Transdermal System - nicotine patch, extended release

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-7066-0Nicotine Transdermal System14 in 1 CARTONPATCH, EXTENDED RELEASE147
60505-7066-0Nicotine Transdermal System1 h in 1 POUCHPATCH, EXTENDED RELEASE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-7066-0EA - Each60505-7066b1f5aa92-6bc2-40ed-8f8c-0e472864483012020-05-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NicotineACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [APOTEX CORP]2
NicotineACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [APOTEX CORP]2
DimethiconeINACTIVE INGREDIENT92RU3N3Y1ONICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [APOTEX CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-7066NICOTINE TRANSDERMAL SYSTEM PATCH, EXTENDED RELEASE [APOTEX CORP]7Legacy NDC, 2 package rows20230707_b0621d9f-9ef8-8876-6bd4-87e46ef1b083.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
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 SystemPSNb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198029nicotine 14 MG/Day 24HR Transdermal SystemSYb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198030nicotine 21 MG/Day 24HR Transdermal SystemSYb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYb0621d9f-9ef8-8876-6bd4-87e46ef1b0837
198031nicotine 7 MG/Day 24HR Transdermal SystemSYb0621d9f-9ef8-8876-6bd4-87e46ef1b0837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-7066-06050570660014 POUCH in 1 CARTON (60505-7066-0) > 1 h in 1 POUCH14 pouch1997-10-200000-00-00NoNoCurrent