NDC 55741-448

Habitrol Step 1

Nicotine Transdermal System Patch

Habitrol Step 1 is a Transdermal Patch, Extended Release in the Human Otc Drug category. It is labeled and distributed by Dr. Reddy's Laboratories Inc.. The primary component is Nicotine.

• Product ID: 55741-448_dab0788a-60c8-316c-7c69-cda848fb1fe7
• NDC: 55741-448
• Product Type: Human Otc Drug
• Proprietary Name: Habitrol Step 1
• Generic Name: Nicotine Transdermal System Patch
• Dosage Form: Patch, Extended Release
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2018-07-13
• Marketing Category: NDA / NDA
• Application Number: NDA020076
• Labeler Name: Dr. Reddy's Laboratories Inc.
• Substance Name: NICOTINE
• Active Ingredient Strength: 21 mg/24h
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55741-448-28

28 PATCH in 1 CARTON (55741-448-28) > 24 h in 1 PATCH

• Marketing Start Date: 2019-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55741-448-10 [55741044810]

Habitrol Step 1 PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020076
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-06-27
• Marketing End Date: 2019-03-25

NDC 55741-448-74 [55741044874]

Habitrol Step 1 PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020076
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-06-15

NDC 55741-448-28 [55741044828]

Habitrol Step 1 PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020076
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-07-01

NDC 55741-448-70 [55741044870]

Habitrol Step 1 PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020076
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-06-15

Drug Details

Active Ingredients

Ingredient	Strength
NICOTINE	21 mg/24h

OpenFDA Data

• SPL SET ID: 051be7ae-6504-c2d8-7424-2e328e4fcfc2
• Manufacturer:
  • Dr. Reddy's Laboratories Inc.
• UNII:
  • 6M3C89ZY6R
• RxNorm Concept Unique ID - RxCUI:
  • 198029
  • 198031
  • 198030
  • 207734
  • 207716
  • 207712

NDC Crossover Matching brand name "Habitrol Step 1" or generic name "Nicotine Transdermal System Patch"

NDC	Brand Name	Generic Name
55741-446	Habitrol	Nicotine Transdermal System Patch
55741-447	Habitrol	Nicotine Transdermal System Patch
55741-448	Habitrol	Nicotine Transdermal System Patch