Habitrol

Product NDC
55741-446
11-digit product format
557410446
Labeler code
55741
Product ID
55741-446_7b8f92dc-a9f4-6c9c-d0ca-bd8f89cbd875
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System Patch
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
NDA020076
Marketing category
NDA
Marketing start
2018-07-13
Substance
NICOTINE
Active strength
7 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 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
Habitrol
Brand name suffix
Step 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE7 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198029Internal RxNorm lookup
198030Internal RxNorm lookup
198031Internal RxNorm lookup
207712Internal RxNorm lookup
207716Internal RxNorm lookup
207734Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
051be7ae-6504-c2d8-7424-2e328e4fcfc2Available 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
55741-446-702024-01-30C16284748780-11030e364-f9cf-111a-e063-dadaa90a10e2Drug Facts
55741-446-742024-01-30C16284748780-11030e364-f9cf-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55741-446-70Habitrol Step 37 in 1 CARTONPATCH, EXTENDED RELEASE712
55741-446-70Habitrol Step 324 h in 1 PATCHPATCH, EXTENDED RELEASE2412
55741-446-74Habitrol Step 314 in 1 CARTONPATCH, EXTENDED RELEASE1412
55741-446-74Habitrol Step 324 h in 1 PATCHPATCH, EXTENDED RELEASE2412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55741-446HABITROL STEP 1 (NICOTINE TRANSDERMAL SYSTEM PATCH ) PATCH, EXTENDED RELEASE HABITROL STEP 2 (NICOTINE TRANSDERMAL SYSTEM PATCH ) PATCH, EXTENDED RELEASE HABITROL STEP 3 (NICOTINE TRANSDERMAL SYSTEM PATCH ) PATCH, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]12Current NDC, Legacy NDC, 4 package rows20240726_051be7ae-6504-c2d8-7424-2e328e4fcfc2.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
ndc (product): 55741-446
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
207716Habitrol (Step 1) 21 MG/Day 24HR Transdermal SystemPSN051be7ae-6504-c2d8-7424-2e328e4fcfc212
207712Habitrol (Step 2) 14 MG/Day 24HR Transdermal SystemPSN051be7ae-6504-c2d8-7424-2e328e4fcfc212
207734Habitrol (Step 3) 7 MG/Day 24HR Transdermal SystemPSN051be7ae-6504-c2d8-7424-2e328e4fcfc212
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN051be7ae-6504-c2d8-7424-2e328e4fcfc212
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN051be7ae-6504-c2d8-7424-2e328e4fcfc212
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN051be7ae-6504-c2d8-7424-2e328e4fcfc212
20773424 HR nicotine 0.292 MG/HR Transdermal System [Habitrol]SBD051be7ae-6504-c2d8-7424-2e328e4fcfc212
20771224 HR nicotine 0.583 MG/HR Transdermal System [Habitrol]SBD051be7ae-6504-c2d8-7424-2e328e4fcfc212
20771624 HR nicotine 0.875 MG/HR Transdermal System [Habitrol]SBD051be7ae-6504-c2d8-7424-2e328e4fcfc212
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD051be7ae-6504-c2d8-7424-2e328e4fcfc212
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD051be7ae-6504-c2d8-7424-2e328e4fcfc212
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD051be7ae-6504-c2d8-7424-2e328e4fcfc212
20773424 HR Habitrol 0.292 MG/HR Transdermal SystemSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
20771224 HR Habitrol 0.583 MG/HR Transdermal SystemSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
20771624 HR Habitrol 0.875 MG/HR Transdermal SystemSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
207716Habitrol (Step 1) 21 MG/Day 24HR Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
207712Habitrol (Step 2) 14 MG/Day 24HR Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
207734Habitrol (Step 3) 7 MG/Day 24HR Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
207734Habitrol (Step 3) 7 MG/Day 24HR Transdermal SystemSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
207734Habitrol 0.292 MG/HR 24HR Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
207712Habitrol 0.583 MG/HR 24 HR Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
207716Habitrol 0.875 MG/HR 24HR Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
198029nicotine 14 MG/Day 24HR Transdermal SystemSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
198030nicotine 21 MG/Day 24HR Transdermal SystemSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY051be7ae-6504-c2d8-7424-2e328e4fcfc212
198031nicotine 7 MG/Day 24HR Transdermal SystemSY051be7ae-6504-c2d8-7424-2e328e4fcfc212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55741-446-70557410446707 PATCH in 1 CARTON (55741-446-70) / 24 h in 1 PATCH7 patch2019-07-010000-00-00NoNoCurrent
55741-446-745574104467414 PATCH in 1 CARTON (55741-446-74) / 24 h in 1 PATCH14 patch2019-06-150000-00-00NoNoCurrent