Over-the-counter drug · ANDA

Nicotine Transdermal System NDC 0363-1243

Nicotine 7 mg/24h · Patch, Extended release · Transdermal · Walgreens

NDC codes

FDA NDC Directory
Product NDC (as listed)0363-1243Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00363-1243Add 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
0363-1243-010036312430114 POUCH in 1 CARTON (0363-1243-01) / 1 h in 1 POUCHMarketed from Sep 30, 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 Transdermal System
Generic name (nonproprietary)
nicotine transdermal system
Active ingredients
Nicotine — 7 mg/24h
Dosage form
Patch, Extended release
Route
Transdermal
Labeler
Walgreens
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074612
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 0363-1243_312d989c-79f6-8f42-e063-6294a90aa812SPL ID 312d989c-79f6-8f42-e063-6294a90aa812SPL set ID 5aadb95f-428c-b637-01f4-50d5866ced0cRxCUI 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

N400363124301 followed by a unit qualifier and the quantity

Package 00363-1243-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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
ProductStrengthForm · routeLabelerProduct NDC
NicotineNicotine 14 mg/24hPatchTransdermalRugby Laboratories0536-5895
NicotineNicotine 21 mg/24hPatchTransdermalRugby Laboratories0536-5896
Nicotine Transdermal SystemNicotine 7 mg/24hPatch, Extended releaseTransdermalCardinal Health70000-0510
Nicotine Transdermal SystemNicotine 14 mg/24hPatch, Extended releaseTransdermalCardinal Health70000-0511
Nicotine Transdermal SystemNicotine 21 mg/24hPatch, Extended releaseTransdermalCardinal Health70000-0512
Nicotine Transdermal SystemNicotine 14 mg/24hPatch, Extended releaseTransdermalH-E-B37808-460
Nicotine Transdermal SystemNicotine 21 mg/24hPatch, Extended releaseTransdermalH-E-B37808-461
Nicotine Transdermal SystemNicotine 14 mg/24hPatch, Extended releaseTransdermalTopco Associates LLC36800-034
Nicotine Transdermal SystemNicotine 7 mg/24hPatch, Extended releaseTransdermalTopco Associates LLC36800-032
Nicotine Transdermal SystemNicotine 21 mg/24hPatch, Extended releaseTransdermalTopco Associates LLC36800-038
MedlinenicotineNicotine 21 mg/1PatchTransdermalMedline Industries, LP53329-192
Nicotine Transdermal SystemNicotine 21 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-353
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalIngenus Pharmaceuticals, LLC50742-668
Nicotine Transdermal SystemNicotine 14 mg/24hPatchTransdermalIngenus Pharmaceuticals, LLC50742-669
Nicotine Transdermal SystemNicotine 14 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-352
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalIngenus Pharmaceuticals, LLC50742-670
Nicotine Transdermal SystemNicotine 14 mg/24hPatch, Extended releaseTransdermalWalgreens0363-1244
Nicotine Transdermal SystemNicotine 7 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-354
Nicotine Transdermal SystemNicotine 21 mg/24hPatch, Extended releaseTransdermalWalgreens0363-1245
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-0122

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