What is NDC 0536-5894?

0536-5894 is the product NDC for Nicotine, Nicotine 7 mg/24h patch, listed with the FDA by Rugby Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.

Rugby Laboratories, NDC labeler code 0536. 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?

194 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nicotine NDC 0536-5894 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0536-5894Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00536-5894Add 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 NDC	11-digit (billing)	Package	Copy
0536-5894-53	00536589453	7 POUCH in 1 CARTON (0536-5894-53) / 1 h in 1 POUCHMarketed from Jun 25, 2024
0536-5894-88	00536589488	14 POUCH in 1 CARTON (0536-5894-88) / 1 h in 1 POUCHMarketed from Jun 25, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary): nicotine
Active ingredients: Nicotine — 7 mg/24h
Dosage form: Patch
Route: Transdermal
Labeler: Rugby LaboratoriesNDC labeler code 0536
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074612
Marketing start: Jun 25, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 0536-5894_1a266044-8837-71cc-e063-6394a90afcc0SPL ID 1a266044-8837-71cc-e063-6394a90afcc0SPL set ID 2dd4cbda-5c46-4655-b69d-21b7d2e912cfRxCUI 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

N400536589453 followed by a unit qualifier and the quantity

Package 00536-5894-53. 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 Jun 5, 2024.

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 0536-5894

What is NDC 0536-5894?: 0536-5894 is the product NDC for Nicotine, Nicotine 7 mg/24h patch, listed with the FDA by Rugby Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nicotine.
What is the active ingredient?: Nicotine.
Who is the labeler?: Rugby Laboratories, NDC labeler code 0536. 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?: 194 other product NDCs are listed under this name. See all Nicotine 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nicotinenicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Amazon.com Services LLC	72288-730	72288-0730-60
nicotinenicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Amazon.com Services LLC	72288-755	72288-0755-06
Nicotinenicotine polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Amazon.com Services LLC	72288-863	72288-0863-06
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Safeway	21130-772	21130-0772-02
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Amazon.com Services LLC	72288-969	72288-0969-76
Nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Amazon.com Services LLC	72288-869	72288-0869-76
Nicotinenicotine polacrilex	Nicotine 2 mg/1	Gum, ChewingBuccal	Cardinal Health 107, LLC	55154-6818	55154-6818-00
nicotinenicotine polacrilex	Nicotine 4 mg/1	LozengeOral	Amazon.com Services LLC	72288-651	72288-0651-14
Nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Walgreen Company	0363-2511	00363-2511-27
nicotinenicotine polacrilex	Nicotine 2 mg/1	LozengeOral	Sixarp, LLC	59368-463	59368-0463-02

All 195 Nicotine NDCs

Other NDCs under ANDA 074612

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

FDA NDC Directory listings under ANDA 074612
Product	Strength	Form · route	Labeler	Product NDC
Nicotine	Nicotine 14 mg/24h	PatchTransdermal	Rugby Laboratories	0536-5895
Nicotine Transdermal System	Nicotine 21 mg/24h	Patch, Extended releaseTransdermal	BluePoint Laboratories	68001-434
Nicotine Transdermal System	Nicotine 7 mg/24h	Patch, Extended releaseTransdermal	BluePoint Laboratories	68001-432
Nicotine Transdermal System	Nicotine 14 mg/24h	Patch, Extended releaseTransdermal	BluePoint Laboratories	68001-433
Nicotine Transdermal System	Nicotine 14 mg/24h	Patch, Extended releaseTransdermal	Cardinal Health	70000-0511
Nicotine Transdermal System	Nicotine 7 mg/24h	PatchTransdermal	Quitine LLC	84720-120
Nicotine Transdermal System	Nicotine 14 mg/24h	PatchTransdermal	Quitine LLC	84720-121
Nicotine Transdermal System	Nicotine 21 mg/24h	PatchTransdermal	Quitine LLC	84720-122
Nicotine Transdermal System	Nicotine 7 mg/24h	Patch, Extended releaseTransdermal	Cardinal Health	70000-0510
Nicotine Transdermal System	Nicotine 21 mg/24h	Patch, Extended releaseTransdermal	Cardinal Health	70000-0512
Nicotine Transdermal System	Nicotine 7 mg/24h	Patch, Extended releaseTransdermal	Walgreens	0363-1243
Nicotine	Nicotine 21 mg/24h	PatchTransdermal	A-S Medication Solutions	50090-1697
Nicotine	Nicotine 21 mg/24h	PatchTransdermal	Rugby Laboratories	0536-5896
Nicotine Transdermal System	Nicotine 21 mg/24h	Patch, Extended releaseTransdermal	Walgreens	0363-1245
Nicotine Transdermal System	Nicotine 21 mg/24h	Patch, Extended releaseTransdermal	H-E-B	37808-461
Nicotine Transdermal System	Nicotine 14 mg/24h	Patch, Extended releaseTransdermal	H-E-B	37808-460
Nicotine Transdermal System	Nicotine 21 mg/24h	Patch, Extended releaseTransdermal	Topco Associates LLC	36800-038
Nicotine Transdermal System	Nicotine 7 mg/24h	Patch, Extended releaseTransdermal	Topco Associates LLC	36800-032
Nicotine Transdermal System	Nicotine 14 mg/24h	Patch, Extended releaseTransdermal	Topco Associates LLC	36800-034
Medlinenicotine	Nicotine 21 mg/1	PatchTransdermal	Medline Industries, LP	53329-192

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