Over-the-counter drug · ANDA

nicotine (Nicotine polacrilex) NDC 37808-617

Nicotine 2 mg/1 · Lozenge · Oral · H E B

NDC codes

FDA NDC Directory
Product NDC (as listed)37808-617Labeler and product segments. Claims need a package NDC.
Product NDC at billing width37808-0617Add 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
37808-617-10378080617104 CONTAINER in 1 CARTON (37808-617-10) / 27 LOZENGE in 1 CONTAINER (37808-617-09)Marketed from Nov 8, 2018

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
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 2 mg/1
Dosage form
Lozenge
Route
Oral
Labeler
H E BNDC labeler code 37808
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203690
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 37808-617_97b9354e-771d-4155-9104-8f81b3fe69c3SPL ID 97b9354e-771d-4155-9104-8f81b3fe69c3SPL set ID b1a13942-1fad-40da-8664-f70574b950d7RxCUI 359817UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N437808061710 followed by a unit qualifier and the quantity

Package 37808-0617-10. 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 37808-617

What is NDC 37808-617?
37808-617 is the product NDC for nicotine (nicotine polacrilex), Nicotine 2 mg/1 lozenge, 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 (Nicotine polacrilex).
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?
197 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-73072288-0730-60
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-75572288-0755-06
Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-86372288-0863-06
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSafeway21130-77221130-0772-02
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-96972288-0969-76
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-86972288-0869-76
Nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingBuccalCardinal Health 107, LLC55154-681855154-6818-00
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-65172288-0651-14
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-251100363-2511-27
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSixarp, LLC59368-46359368-0463-02

All 198 nicotine NDCs

Other NDCs under ANDA 203690

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

FDA NDC Directory listings under ANDA 203690
ProductStrengthForm · routeLabelerProduct NDC
Mini Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralMeijer, Inc.79481-0957
members mark Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSam's West Inc68196-734
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralPublix Super Markets Inc56062-957
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralPublix Super Markets Inc56062-734
Nicotine Mininicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-375
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralCVS Pharmacy59779-957
nicotine mininicotine polacrilexNicotine 4 mg/1LozengeOralWalgreen Company0363-1130
Topcare Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTopco Associates LLC36800-957
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-7969
mini nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralMeijer Distribution Inc41250-587
good sense nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-7999
berkley and jensen nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralBJWC68391-734
NicotineNicotine 2 mg/1LozengeOralH E B37808-900
mini nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralMeijer Distribution Inc41250-637
berkley and jensen nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralBJWC68391-957
members mark mini nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralSam's West Inc68196-957
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralKroger Company30142-696
Blipnicotine polacrilexNicotine 2 mg/1LozengeOralBlip Products, Inc.82966-222
Blipnicotine polacrilexNicotine 4 mg/1LozengeOralBlip Products, Inc.82966-303
Nicotine Mininicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-7051

Showing 20 of 40.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in