Over-the-counter drug · NDA

Nicotine transdermal system step 3 NDC 50090-6383

nicotine · Nicotine 7 mg/24h · Patch, Extended release · Transdermal · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6383Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6383Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50090-6383-05009063830014 PATCH in 1 CARTON (50090-6383-0) / 24 h in 1 PATCHMarketed from Feb 28, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Nicotine transdermal system step 3Suffix: transdermal system step 3
Generic name (nonproprietary)
nicotine
Active ingredients
Nicotine — 7 mg/24h
Dosage form
Patch, Extended release
Route
Transdermal
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020076
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 50090-6383_adc8730d-7b7a-4e5c-a3a1-6466ea45f0beSPL ID adc8730d-7b7a-4e5c-a3a1-6466ea45f0beSPL set ID 798a66fa-25d8-4713-b25f-56875431e37dRxCUI 198031UNII 6M3C89ZY6R
Pharmacologic class
Cholinergic Nicotinic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450090638300 followed by a unit qualifier and the quantity

Package 50090-6383-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020076

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020076
ProductStrengthForm · routeLabelerProduct NDC
Nicotine Transdermal SystemnicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalA-S Medication Solutions50090-7936
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalRugby Laboratories0536-1108
Habitrol Step 2nicotine transdermal system patchNicotine 14 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.55741-447
Nicotine Transdermalnicotine—KitTransdermalRite Aid Corporation11822-3627
Habitrol Step 3nicotine transdermal system patchNicotine 7 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.55741-446
Habitrol Step 1nicotine transdermal system patchNicotine 21 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.55741-448
nicotine transdermal systemnicotine—KitTransdermalDr. Reddy's Laboratories Inc.55741-449
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.43598-448
Nicotine transdermal system step 3nicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.43598-446
Nicotine transdermal system step 2nicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.43598-447
Nicotine transdermal system step 3nicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalRite Aid Corporation11822-4973
Nicotine transdermal system step 2nicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalRite Aid Corporation11822-4974
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalRite Aid Corporation11822-4975
Nicotine transdermal system step 3nicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalCVS Pharmacy59779-443
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalCVS Pharmacy59779-448
Nicotine transdermal system step 2nicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalCVS Pharmacy59779-445
Nicotine Transdermal System step 3nicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-831
Nicotine Transdermal System step 2nicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-832
Nicotine Transdermal System step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-833
Nicotine transdermal system step 3nicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalGolden State Medical Supply, Inc.60429-443

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