Over-the-counter drug · NDA AUTHORIZED GENERIC

Nicotine transdermal system (Nicotine) NDC 49035-194

Nicotine 21 mg/24h · Patch, Extended release · Transdermal · Wal-Mart Stores Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)49035-194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0194Add 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
49035-194-0149035019401490350194017 PATCH in 1 CARTON (49035-194-01) / 24 h in 1 PATCHMarketed from Oct 19, 2010
49035-194-02490350194024903501940214 PATCH in 1 CARTON (49035-194-02) / 24 h in 1 PATCHMarketed from Oct 19, 2010

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 systemSuffix: transdermal system
Generic name (nonproprietary)
nicotine
Active ingredients
Nicotine — 21 mg/24h
Dosage form
Patch, Extended release
Route
Transdermal
Labeler
Wal-Mart Stores IncNDC labeler code 49035
Product type
Over-the-counter drug
Marketing category
NDA authorized genericApplication NDA 020165
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 49035-194_085e5042-be1f-49ea-88a8-804fc969824fSPL ID 085e5042-be1f-49ea-88a8-804fc969824fSPL set ID aefd30c4-35d5-425e-855c-327a7c436188RxCUI 198029, 198030, 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

N449035019401 followed by a unit qualifier and the quantity

Package 49035-0194-01. 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)

About NDC 49035-194

What is NDC 49035-194?
49035-194 is the product NDC for Nicotine transdermal system (nicotine), Nicotine 21 mg/24h patch, extended release, listed with the FDA by Wal-Mart Stores Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nicotine transdermal system (Nicotine).
What is the active ingredient?
Nicotine.
Who is the labeler?
Wal-Mart Stores Inc, NDC labeler code 49035. 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 14 mg/24hPatch, Extended releaseTransdermalWal-Mart Stores Inc49035-195
Nicotine transdermal systemnicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalWal-Mart Stores Inc49035-196
Nicotine transdermal systemnicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalSam's West Inc68196-194

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