Over-the-counter drug · NDA

Nicotine transdermal system (Nicotine) NDC 68196-194

Nicotine 21 mg/24h · Patch, Extended release · Transdermal · Sam's West Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)68196-194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68196-0194Add the package segment from the table below.

Product information

Brand name (proprietary)
Nicotine transdermal systemSuffix: transdermal system
Generic name (nonproprietary)
nicotine
Active ingredients
Nicotine — 21 mg/24h
Dosage form
Patch, Extended release
Route
Transdermal
Labeler
Sam's West IncNDC labeler code 68196
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020165
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 68196-194_0688260f-58f8-41f6-8b77-4e16833f58ccSPL ID 0688260f-58f8-41f6-8b77-4e16833f58ccSPL set ID cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7RxCUI 198030UNII 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.

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)

About NDC 68196-194

What is NDC 68196-194?
68196-194 is the product NDC for Nicotine transdermal system (nicotine), Nicotine 21 mg/24h patch, extended release, listed with the FDA by Sam's West Inc.
What drug is associated with this NDC?
Nicotine transdermal system (Nicotine).
What is the active ingredient?
Nicotine.
Who is the labeler?
Sam's West Inc, NDC labeler code 68196. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nicotine transdermal system?
42 other product NDCs are listed under this name. See all Nicotine transdermal system NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nicotine transdermal system NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalIngenus Pharmaceuticals, LLC50742-66850742-0668-0750742-0668-14
Nicotine Transdermal SystemNicotine 14 mg/24hPatchTransdermalIngenus Pharmaceuticals, LLC50742-66950742-0669-0750742-0669-1450742-0669-28
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalIngenus Pharmaceuticals, LLC50742-67050742-0670-0750742-0670-1450742-0670-28
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalQuitine LLC84720-12084720-0120-14
Nicotine Transdermal SystemNicotine 14 mg/24hPatchTransdermalQuitine LLC84720-12184720-0121-14
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalQuitine LLC84720-12284720-0122-1484720-0122-28
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-012003215-0120-14
Nicotine Transdermal SystemNicotine 14 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-012103215-0121-14
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-012203215-0122-14
Nicotine Transdermal SystemnicotineNicotine 7 mg/24hFilm, Extended releaseTransdermalEXELAN PHARMACEUTICALS, INC.76282-78176282-0781-40

All 43 Nicotine transdermal system NDCs

Other NDCs under NDA 020165

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

FDA NDC Directory listings under NDA 020165
ProductStrengthForm · routeLabelerProduct NDC
Nicoderm CqnicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalHaleon US Holdings LLC0135-0194
Nicoderm CqnicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalHaleon US Holdings LLC0135-0195
Nicoderm CqnicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalHaleon US Holdings LLC0135-0196
Nicotine transdermal systemnicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalTarget Corporation11673-194
Nicotine transdermal systemnicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalTarget Corporation11673-195
Nicotine transdermal systemnicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalTarget Corporation11673-196
Nicotine transdermal systemnicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalWal-Mart Stores Inc49035-194
Nicotine transdermal systemnicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalWal-Mart Stores Inc49035-195
Nicotine transdermal systemnicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalWal-Mart Stores Inc49035-196

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in