Over-the-counter drug · ANDA

Nicotine Transdermal System NDC 37808-461

Nicotine 21 mg/24h · Patch, Extended release · Transdermal · H-E-B

NDC codes

FDA NDC Directory
Product NDC (as listed)37808-461Labeler and product segments. Claims need a package NDC.
Product NDC at billing width37808-0461Add 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
37808-461-01378080461013780804610114 POUCH in 1 CARTON (37808-461-01) / 1 h in 1 POUCHMarketed from Jun 25, 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 — 21 mg/24h
Dosage form
Patch, Extended release
Route
Transdermal
Labeler
H-E-BNDC labeler code 37808
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 37808-461_4c5ae925-c022-9e90-e063-6394a90a50faSPL ID 4c5ae925-c022-9e90-e063-6394a90a50faSPL set ID da35e19d-b0aa-8a5f-140e-7601bd2027feRxCUI 198029, 198030UNII 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

N437808046101 followed by a unit qualifier and the quantity

Package 37808-0461-01. 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 37808-461

What is NDC 37808-461?
37808-461 is the product NDC for Nicotine Transdermal System, Nicotine 21 mg/24h patch, extended release, listed with the FDA by H-E-B. It has 1 package NDC, 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?
H-E-B, NDC labeler code 37808. 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 21 mg/24hPatchTransdermalQuitine LLC84720-12284720-0122-1484720-0122-28
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalQuitine LLC84720-12084720-0120-14
Nicotine Transdermal SystemNicotine 14 mg/24hPatchTransdermalQuitine LLC84720-12184720-0121-14
Nicotine Transdermal SystemNicotine 14 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-012103215-0121-14
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-012003215-0120-14
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-012203215-0122-14
Nicotine Transdermal SystemnicotineNicotine 14 mg/24hFilm, Extended releaseTransdermalEXELAN PHARMACEUTICALS, INC.76282-78276282-0782-40

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
foster and thrive STEP 1nicotine transdermal systemNicotine 21 mg/24hPatchTransdermalStrategic Sourcing Services LLC70677-1182
foster and thrive STEP 2nicotine transdermal systemNicotine 14 mg/24hPatchTransdermalStrategic Sourcing Services LLC70677-1181
foster and thrive STEP 3nicotine transdermal systemNicotine 7 mg/24hPatchTransdermalStrategic Sourcing Services LLC70677-1180
MedlinenicotineNicotine 21 mg/1PatchTransdermalMedline Industries, LP53329-192
NicotineNicotine 7 mg/24hPatchTransdermalRugby Laboratories0536-5894
NicotineNicotine 14 mg/24hPatchTransdermalRugby Laboratories0536-5895
NicotineNicotine 21 mg/24hPatchTransdermalRugby Laboratories0536-5896
NicotineNicotine 14 mg/24hPatchTransdermalA-S Medication Solutions50090-1148
NicotineNicotine 7 mg/24hPatchTransdermalA-S Medication Solutions50090-1694
NicotineNicotine 21 mg/24hPatchTransdermalA-S Medication Solutions50090-1697
NicotineNicotine 21 mg/24hPatchTransdermalStrategic Sourcing Services LLC70677-0032
NicotineNicotine 21 mg/24hPatchTransdermalMeijer, Inc.79481-0052
NicotineNicotine 14 mg/24hPatchTransdermalMeijer, Inc.79481-0053
NicotineNicotine 7 mg/24hPatchTransdermalMeijer, Inc.79481-0054
Nicotine Transdermal SystemNicotine 7 mg/24hPatch, Extended releaseTransdermalWalgreens0363-1243
Nicotine Transdermal SystemNicotine 14 mg/24hPatch, Extended releaseTransdermalWalgreens0363-1244
Nicotine Transdermal SystemNicotine 21 mg/24hPatch, Extended releaseTransdermalWalgreens0363-1245
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.3215-0122

Showing 20 of 39.

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