FDA.reportPublic FDA data

Medline

Product NDC
53329-193
11-digit product format
533290193
Labeler code
53329
Product ID
53329-193_42c99420-c566-55f4-e063-6294a90ad873
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Medline Industries, LP
Application
ANDA074645
Marketing category
ANDA
Marketing start
2022-06-30
Substance
NICOTINE
Active strength
7 mg/1
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.

Additional Listing Data#

Finished product
Yes
Brand name base
Medline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE7 mg/1

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 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e11a4b7e-6f1f-24db-e053-2a95a90a0d09Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-193-09Medline1 in 1 POUCHPATCH18
53329-193-89Medline14 in 1 CARTONPATCH148

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-193MEDLINE (NICOTINE) PATCH [MEDLINE INDUSTRIES, LP]7Current NDC, Legacy NDC, 2 package rows20250327_e11a4b7e-6f1f-24db-e053-2a95a90a0d09.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineNICOTINEMedline Industries, LPe11a4b7e-6f1f-24db-e053-2a95a90a0d092025-11-04WarningsExact identifier
application applno (ANDA): 074645
application number: ANDA074645
ndc (product): 53329-193

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNe11a4b7e-6f1f-24db-e053-2a95a90a0d098
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDe11a4b7e-6f1f-24db-e053-2a95a90a0d098
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDe11a4b7e-6f1f-24db-e053-2a95a90a0d098
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198029nicotine 14 MG/Day 24HR Transdermal SystemSYe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198030nicotine 21 MG/Day 24HR Transdermal SystemSYe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYe11a4b7e-6f1f-24db-e053-2a95a90a0d098
198031nicotine 7 MG/Day 24HR Transdermal SystemSYe11a4b7e-6f1f-24db-e053-2a95a90a0d098

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-193-09533290193091 in 1 POUCHHistorical
53329-193-895332901938914 POUCH in 1 CARTON (53329-193-89) / 1 PATCH in 1 POUCH (53329-193-09) 14 pouch2022-08-280000-00-00NoNoCurrent