Over-the-counter drug · ANDA

Nicotine Transdermal System NDC 3215-1203

Nicotine 21 mg/24h · Patch · Transdermal · Aveva Drug Delivery Systems Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)3215-1203Labeler and product segments. Claims need a package NDC.
Product NDC at billing width03215-1203Add 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
3215-1203-07032151203077 POUCH in 1 CARTON (3215-1203-07) / 24 h in 1 POUCHMarketed from Jun 25, 2024
3215-1203-140321512031414 POUCH in 1 CARTON (3215-1203-14) / 24 h in 1 POUCHMarketed from Jun 25, 2024
3215-1203-280321512032828 POUCH in 1 CARTON (3215-1203-28) / 24 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 Transdermal System
Generic name (nonproprietary)
nicotine transdermal system
Active ingredients
Nicotine — 21 mg/24h
Dosage form
Patch
Route
Transdermal
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 3215-1203_3b26fb9e-e895-8cf8-e063-6294a90af3b5SPL ID 3b26fb9e-e895-8cf8-e063-6294a90af3b5SPL set ID 7cdad3b0-82d5-400f-a7f5-ac2e9d4478feRxCUI 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

N403215120307 followed by a unit qualifier and the quantity

Package 03215-1203-07. 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 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 7 mg/24hPatch, Extended releaseTransdermalWalgreens0363-1243
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

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