NICOTINE

Product NDC
50090-2837
11-digit product format
500902837
Labeler code
50090
Product ID
50090-2837_f7741174-71a1-4951-8d30-8f42db1bd8fb
Type
HUMAN OTC DRUG
Nonproprietary name
NICOTINE
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
A-S Medication Solutions
Application
NDA020076
Marketing category
NDA
Marketing start
2015-05-14
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

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
50090-2837-02024-01-30C16284748780-11030e365-194a-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2837-0NICOTINE TRANSDERMAL SYSTEM STEP 114 in 1 CARTONPATCH, EXTENDED RELEASE1410
50090-2837-0NICOTINE TRANSDERMAL SYSTEM STEP 124 h in 1 PATCHPATCH, EXTENDED RELEASE2410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2837-0EA - Each50090-2837130c4454-6355-4430-a1d4-0e436314c5f412023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2837NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]10Legacy NDC, 2 package rows20221206_f7b564df-4a69-48cc-a0b0-8f8bedd64d80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
198030nicotine 21 MG/Day 24HR Transdermal SystemSYf7b564df-4a69-48cc-a0b0-8f8bedd64d8010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2837-05009028370014 PATCH in 1 CARTON (50090-2837-0) > 24 h in 1 PATCH14 patch2017-02-030000-00-00NoNoCurrent