FDA.reportPublic FDA data

Habitrol

Product NDC
55741-448
11-digit product format
557410448
Labeler code
55741
Product ID
55741-448_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
21 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Habitrol
Brand name suffix
Step 1
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE21 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui198029, 198030, 198031, 207712, 207716, 207734

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
55741-448-282024-01-30C16284748780-11030e364-f9cf-111a-e063-dadaa90a10e2Drug Facts
55741-448-702024-01-30C16284748780-11030e364-f9cf-111a-e063-dadaa90a10e2Drug Facts
55741-448-742024-01-30C16284748780-11030e364-f9cf-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55741-448-28Habitrol Step 128 in 1 CARTONPATCH, EXTENDED RELEASE2812
55741-448-28Habitrol Step 124 h in 1 PATCHPATCH, EXTENDED RELEASE2412
55741-448-70Habitrol Step 17 in 1 CARTONPATCH, EXTENDED RELEASE712
55741-448-70Habitrol Step 124 h in 1 PATCHPATCH, EXTENDED RELEASE2412
55741-448-74Habitrol Step 114 in 1 CARTONPATCH, EXTENDED RELEASE1412
55741-448-74Habitrol Step 124 h in 1 PATCHPATCH, EXTENDED RELEASE2412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55741-448-70EA - Each55741-448a712a4d5-d831-41d5-8e45-c3ba115b293012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55741-448HABITROL 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, 6 package rows20240726_051be7ae-6504-c2d8-7424-2e328e4fcfc2.zip

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
55741-448-285574104482828 PATCH in 1 CARTON (55741-448-28) / 24 h in 1 PATCH28 patch2019-07-010000-00-00NoNoCurrent
55741-448-70557410448707 PATCH in 1 CARTON (55741-448-70) / 24 h in 1 PATCH7 patch2019-06-150000-00-00NoNoCurrent
55741-448-745574104487414 PATCH in 1 CARTON (55741-448-74) / 24 h in 1 PATCH14 patch2019-06-150000-00-00NoNoCurrent