nicotine

Product NDC
55741-449
11-digit product format
557410449
Labeler code
55741
Product ID
55741-449_bed562f2-f5b3-632b-4b2c-fdf34a061098
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
KIT
Route
TRANSDERMAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
NDA020076
Marketing category
NDA
Marketing start
2015-05-14
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 productproduct55741-449DDiscontinued by firm2026-08-17
excluded packagepackage55741-44955741-449-56DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55741-449-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55741-449-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55741-449-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55741-449-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55741-449-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55741-449-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55741-449-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55741-449-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55741-449-560efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55741-449-56ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55741-449-56367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55741-449-56557ba5c1ecfa…9c80585c8c6e…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
nicotine
Brand name suffix
transdermal system
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198029Internal RxNorm lookup
198030Internal RxNorm lookup
198031Internal RxNorm lookup
892244Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9946e3c-80c9-3076-7c32-e2988ac07048Available on FDA.report

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
55741-449-562024-01-30C16284748780-11030e365-5685-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55741-449-56nicotine transdermal system56 in 1 CARTONKIT564
55741-449-56nicotine transdermal system1 in 1 PATCHKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55741-449NICOTINE TRANSDERMAL SYSTEM (NICOTINE) KIT [DR. REDDY'S LABORATORIES INC.]4Current NDC, Legacy NDC, 2 package rows20240726_b9946e3c-80c9-3076-7c32-e2988ac07048.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 · 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
ndc (product): 55741-449
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
892244{14 (24 HR nicotine 0.292 MG/HR Transdermal System) / 14 (24 HR nicotine 0.583 MG/HR Transdermal System) / 28 (24 HR nicotine 0.875 MG/HR Transdermal System) } PackGPCKb9946e3c-80c9-3076-7c32-e2988ac070484
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNb9946e3c-80c9-3076-7c32-e2988ac070484
892244nicotine 21 MG-14 MG-7 MG 24 HR Transdermal System Kit (56)PSNb9946e3c-80c9-3076-7c32-e2988ac070484
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNb9946e3c-80c9-3076-7c32-e2988ac070484
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNb9946e3c-80c9-3076-7c32-e2988ac070484
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDb9946e3c-80c9-3076-7c32-e2988ac070484
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDb9946e3c-80c9-3076-7c32-e2988ac070484
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDb9946e3c-80c9-3076-7c32-e2988ac070484
892244{28 (nicotine 21 MG per 24HR 1 Day Transdermal Patch) / 14 (nicotine 14 MG per 24HR 1 Day Transdermal Patch) / 14 (nicotine 7 MG per 24HR 1 Day Transdermal Patch) } PackSYb9946e3c-80c9-3076-7c32-e2988ac070484
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
198029nicotine 14 MG/Day 24HR Transdermal SystemSYb9946e3c-80c9-3076-7c32-e2988ac070484
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
198030nicotine 21 MG/Day 24HR Transdermal SystemSYb9946e3c-80c9-3076-7c32-e2988ac070484
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYb9946e3c-80c9-3076-7c32-e2988ac070484
892244nicotine 7 MG-14 MG-21 MG in 24 HR Transdermal System KitSYb9946e3c-80c9-3076-7c32-e2988ac070484
198031nicotine 7 MG/Day 24HR Transdermal SystemSYb9946e3c-80c9-3076-7c32-e2988ac070484

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55741-449-565574104495656 PATCH in 1 CARTON (55741-449-56) / 1 KIT in 1 PATCH56 patch2015-05-140000-00-00NoNoCurrent