Over-the-counter drug · ANDA

Nicotine Transdermal System NDC 68001-433

Nicotine 14 mg/24h · Patch, Extended release · Transdermal · BluePoint Laboratories

NDC codes

FDA NDC Directory
Product NDC (as listed)68001-433Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0433Add 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
68001-433-8868001043388680010433887 POUCH in 1 CARTON (68001-433-88) / 1 h in 1 POUCHMarketed from Jun 27, 2024
68001-433-90680010433906800104339014 POUCH in 1 CARTON (68001-433-90) / 1 h in 1 POUCHMarketed from Jun 27, 2024

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 System
Generic name (nonproprietary)
nicotine transdermal system
Active ingredients
Nicotine — 14 mg/24h
Dosage form
Patch, Extended release
Route
Transdermal
Labeler
BluePoint LaboratoriesNDC labeler code 68001
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 68001-433_312dca25-59f8-dffd-e063-6394a90adc8cSPL ID 312dca25-59f8-dffd-e063-6394a90adc8cSPL set ID a8a769ce-e41a-696f-e053-2a95a90a6b18RxCUI 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

N468001043388 followed by a unit qualifier and the quantity

Package 68001-0433-88. 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 68001-433

What is NDC 68001-433?
68001-433 is the product NDC for Nicotine Transdermal System, Nicotine 14 mg/24h patch, extended release, listed with the FDA by BluePoint Laboratories. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nicotine Transdermal System.
What is the active ingredient?
Nicotine.
Who is the labeler?
BluePoint Laboratories, NDC labeler code 68001. 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 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
Nicotine Transdermal SystemNicotine 14 mg/24hPatch, Extended releaseTransdermalTopco Associates LLC36800-034
Nicotine Transdermal SystemNicotine 7 mg/24hPatch, Extended releaseTransdermalTopco Associates LLC36800-032
NicotineNicotine 21 mg/24hPatchTransdermalRugby Laboratories0536-5896
Nicotine Transdermal SystemNicotine 21 mg/24hPatch, Extended releaseTransdermalTopco Associates LLC36800-038
Nicotine Transdermal SystemNicotine 7 mg/24hPatch, Extended releaseTransdermalCardinal Health70000-0510
NicotineNicotine 21 mg/24hPatchTransdermalStrategic Sourcing Services LLC70677-0032
Nicotine Transdermal SystemNicotine 7 mg/24hPatch, Extended releaseTransdermalBluePoint Laboratories68001-432
Nicotine Transdermal SystemNicotine 21 mg/24hPatch, Extended releaseTransdermalBluePoint Laboratories68001-434
Nicotine Transdermal SystemNicotine 14 mg/24hPatch, Extended releaseTransdermalCardinal Health70000-0511
Nicotine Transdermal SystemNicotine 21 mg/24hPatch, Extended releaseTransdermalCardinal Health70000-0512
Nicotine Transdermal SystemNicotine 7 mg/24hPatch, Extended releaseTransdermalWalgreens0363-1243
Nicotine Transdermal SystemNicotine 14 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-352
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-0122
Nicotine Transdermal SystemNicotine 21 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-353
Nicotine Transdermal SystemNicotine 7 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-354
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-0120
Nicotine Transdermal SystemNicotine 14 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-0121
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalAveva Drug Delivery Systems Inc.3215-1203
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalAveva Drug Delivery Systems Inc.3215-1201
Nicotine Transdermal SystemNicotine 14 mg/24hPatch, Extended releaseTransdermalWalgreens0363-1244

Showing 20 of 39.

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