NDC codes

FDA NDC Directory
Product NDC (as listed)37808-674Labeler and product segments. Claims need a package NDC.
Product NDC at billing width37808-0674Add 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
37808-674-03378080674031 CONTAINER in 1 CARTON (37808-674-03) / 24 LOZENGE in 1 CONTAINERMarketed from Apr 16, 2019
37808-674-10378080674104 CONTAINER in 1 CARTON (37808-674-10) / 27 LOZENGE in 1 CONTAINERMarketed from Apr 16, 2019

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 lozenge
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 077007
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 37808-674_f186f7fc-7b7a-4029-a404-99e5f2e1f557SPL ID f186f7fc-7b7a-4029-a404-99e5f2e1f557SPL set ID db78d030-7abf-494f-94ca-4a385f519fafRxCUI 359817UNII 6M3C89ZY6RUPC 0012345678905
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

N437808067403 followed by a unit qualifier and the quantity

Package 37808-0674-03. 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 37808-674

What is NDC 37808-674?
37808-674 is the product NDC for nicotine lozenge (nicotine polacrilex), Nicotine 2 mg/1 lozenge, listed with the FDA by H E B. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
nicotine lozenge (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 lozenge?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 077007

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

FDA NDC Directory listings under ANDA 077007
ProductStrengthForm · routeLabelerProduct NDC
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-0344
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralPublix Super Markets Inc56062-671
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-873
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-5023
quitine nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralQUITINE LLC84720-000
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralStrategic Sourcing Services LLC70677-1177
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralCVS Pharmacy69842-587
foster and thrive nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralStrategic Sourcing Services LLC70677-1176
up and up nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTarget Corporation82442-741
quitine nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralQUITINE LLC84720-007
Nicotine PolacrilexNicotine 2 mg/1LozengeOralPadagis Israel Pharmaceuticals Ltd45802-344
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralCVS Pharmacy69842-595
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-969
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-344
nicotine coatednicotine polacrilexNicotine 2 mg/1LozengeOralPublix Super Markets Inc56062-543
Quitine Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralQUITINE LLC84720-222
Quitine Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralQUITINE LLC84720-400
up and up mint nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralTarget Corporation82442-873
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralPublix Super Markets Inc56062-636
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralCVS Pharmacy59779-873

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