nicotine transdermal system step 1

Generic: nicotine

Labeler: dr. reddy's laboratories inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicotine transdermal system step 1
Generic Name nicotine
Labeler dr. reddy's laboratories inc.
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

nicotine 21 mg/24h

Manufacturer
Dr. Reddy's Laboratories Inc.

Identifiers & Regulatory

Product NDC 43598-448
Product ID 43598-448_15710e2c-e365-1726-06de-fb172f976a3b
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020076
Listing Expiration 2026-12-31
Marketing Start 2015-05-14

Pharmacologic Class

Established (EPC)
cholinergic nicotinic agonist [epc]
Chemical Structure
nicotine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598448
Hyphenated Format 43598-448

Supplemental Identifiers

RxCUI
198029 198030 198031
UNII
6M3C89ZY6R
NUI
N0000175706 M0014836

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nicotine transdermal system step 1 (source: ndc)
Generic Name nicotine (source: ndc)
Application Number NDA020076 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • 21 mg/24h
source: ndc
Packaging
  • 28 PATCH in 1 CARTON (43598-448-28) / 24 h in 1 PATCH
  • 7 PATCH in 1 CARTON (43598-448-70) / 24 h in 1 PATCH
  • 14 PATCH in 1 CARTON (43598-448-74) / 24 h in 1 PATCH
source: ndc

Packages (3)

43598-448-28 28 PATCH in 1 CARTON (43598-448-28) / 24 h in 1 PATCH 43598-448-70 7 PATCH in 1 CARTON (43598-448-70) / 24 h in 1 PATCH 43598-448-74 14 PATCH in 1 CARTON (43598-448-74) / 24 h in 1 PATCH

Ingredients (1)

nicotine (21 mg/24h)

Linked Drug Pages (1)

Nicotine transdermal system step 3, Nicotine transdermal system step 2, Nicotine transdermal system step 1 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "15710e2c-e365-1726-06de-fb172f976a3b", "openfda": {"nui": ["N0000175706", "M0014836"], "unii": ["6M3C89ZY6R"], "rxcui": ["198029", "198030", "198031"], "spl_set_id": ["3a68eb70-0548-fa6f-8b1c-375e8799f24f"], "pharm_class_cs": ["Nicotine [CS]"], "pharm_class_epc": ["Cholinergic Nicotinic Agonist [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 PATCH in 1 CARTON (43598-448-28)  / 24 h in 1 PATCH", "package_ndc": "43598-448-28", "marketing_start_date": "20190331"}, {"sample": false, "description": "7 PATCH in 1 CARTON (43598-448-70)  / 24 h in 1 PATCH", "package_ndc": "43598-448-70", "marketing_start_date": "20190331"}, {"sample": false, "description": "14 PATCH in 1 CARTON (43598-448-74)  / 24 h in 1 PATCH", "package_ndc": "43598-448-74", "marketing_start_date": "20190331"}], "brand_name": "Nicotine transdermal system step 1", "product_id": "43598-448_15710e2c-e365-1726-06de-fb172f976a3b", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Cholinergic Nicotinic Agonist [EPC]", "Nicotine [CS]"], "product_ndc": "43598-448", "generic_name": "Nicotine", "labeler_name": "Dr. Reddy's Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nicotine", "brand_name_suffix": "transdermal system step 1", "active_ingredients": [{"name": "NICOTINE", "strength": "21 mg/24h"}], "application_number": "NDA020076", "marketing_category": "NDA", "marketing_start_date": "20150514", "listing_expiration_date": "20261231"}