LEADER NICOTINE TRANSDERMAL SYSTEM

Product NDC
37205-358
11-digit product format
372050358
Labeler code
37205
Product ID
37205-358_36deb649-005e-4971-ab69-57dbba14b06c
Type
HUMAN OTC DRUG
Nonproprietary name
NICOTINE
Dosage form
PATCH, EXTENDED RELEASE
Route
TOPICAL
Labeler
Cardinal Health
Application
NDA020076
Marketing category
NDA
Marketing start
2012-01-02
Marketing end
0000-00-00
Substance
NICOTINE
Active strength
21 mg/24h
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct37205-358DDiscontinued by firm2026-08-17
excluded packagepackage37205-35837205-358-74DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37205-358-74DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37205-358-74DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37205-358-74IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37205-358-74IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37205-358-74IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37205-358-74IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37205-358-74IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37205-358-74IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37205-358-74IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37205-358-74IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37205-358-74IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37205-358-74IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage37205-358-74IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage37205-358-74IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage37205-358-74IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage37205-358-74IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage37205-358-74IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage37205-358-74IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage37205-358-74IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage37205-358-74IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage37205-358-74IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage37205-358-74EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
N020076-004HABITROLNICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-005HABITROLNICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-006HABITROLNICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12

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 06:07:402026-07N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-121e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-358-742025-04-15C16284748780-19d75b9d0-135d-f424-e053-dadaa90a57ceDrug Facts
37205-358-742020-01-31C16284748780-19d75b9d0-135d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-358-74EA - Each37205-35851d51754-c810-4b6d-a431-30dd856cb03012012-07-24

DailyMed Socrata Ingredients#

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Transdermal System Patch Step 3NICOTINE TRANSDERMAL SYSTEM PATCHBluePoint Laboratories4856e99a-badc-b957-e063-6294a90a86062026-07-10WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine Transdermal System step 3NICOTINEAmerisourceBergen Drug Corporatione51d2c09-a20f-eb9b-e3e4-013f3e488ab32026-07-01WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINERugby Laboratoriesae406389-0f83-d5c8-bd2f-56075e57453a2026-03-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine Transdermal System step 3NICOTINECARDINAL HEALTH 110, LLC. DBA LEADERdbbed17b-8ad3-05fb-fb63-03fbb75eae052026-03-18WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
NICOTINE TRANSDERMAL SYSTEMNICOTINEA-S Medication Solutionscfb56e3e-ac5d-4086-a5d3-23080844b3e12026-03-13WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEGolden State Medical Supply, Inc.7c83d507-7e8d-496c-bb9d-63abfa25c7a72025-04-17WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINECVS Pharmacyd51d5224-f5bf-2510-1fa0-c4bb454f81602024-12-01WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEStrategic Sourcing Services LLC6c0b5b5c-cc76-6e48-c364-4db0e081557d2024-11-09WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINERite Aid Corporationd2e32434-ec58-943e-dbeb-8e73315315952024-07-26WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
NICOTINE TRANSDERMALNICOTINERite Aid Corporationae6027da-5c96-ed47-e1ae-e900fc0f72ce2024-07-26WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEThe Kroger Co.13cdd780-4196-685b-3cab-f9694a3276182024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Habitrol Step 3NICOTINE TRANSDERMAL SYSTEM PATCHDr. Reddy's Laboratories Inc.051be7ae-6504-c2d8-7424-2e328e4fcfc22024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 2NICOTINEChain Drug Marketing Association INCdf1348cb-0d15-7e4b-921c-d8764c858e662024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal systemNICOTINEDr. Reddys Laboratories Inc.e2391b29-9bac-fc09-f2a5-a3370bc4e2c32024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
nicotine transdermal systemNICOTINEDr. Reddy's Laboratories Inc.b9946e3c-80c9-3076-7c32-e2988ac070482024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 1NICOTINEDOLGENCORP, LLC81e55db2-897e-e567-5743-63179783291a2024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEWalgreens Companyde471db4-b332-0490-198d-d354802728742024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEDr. Reddy's Laboratories Inc.3a68eb70-0548-fa6f-8b1c-375e8799f24f2024-07-24WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEA-S Medication Solutions798a66fa-25d8-4713-b25f-56875431e37d2023-03-02WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076