NDC codes

FDA NDC Directory
Product NDC (as listed)37808-533Labeler and product segments. Claims need a package NDC.
Product NDC at billing width37808-0533Add 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
37808-533-1037808053310378080533104 CONTAINER in 1 CARTON (37808-533-10) / 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
Generic name (nonproprietary)
nicotine
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 090711
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 37808-533_56f142f0-fb0c-4e01-91a0-50ce317d8962SPL ID 56f142f0-fb0c-4e01-91a0-50ce317d8962SPL set ID 691f3f8d-7242-4855-b80b-4d5af0490b37RxCUI 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

N437808053310 followed by a unit qualifier and the quantity

Package 37808-0533-10. 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 37808-533

What is NDC 37808-533?
37808-533 is the product NDC for nicotine, 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.
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 2 mg/1Gum, ChewingOralAmazon.com Services LLC72288-68472288-0684-02
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

All 198 nicotine NDCs

Other NDCs under ANDA 090711

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

FDA NDC Directory listings under ANDA 090711
ProductStrengthForm · routeLabelerProduct NDC
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-124
Basic Care Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-190
equate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-124
Equate Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-190
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-1125
good sense nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-1190
Kirkland Signature NicotinenicotineNicotine 2 mg/1LozengeOralCostco Wholesale Company63981-124
Kirkland Signature NicotinenicotineNicotine 4 mg/1LozengeOralCostco Wholesale Company63981-190
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-0124
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWalgreen Company0363-4190
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralRite Aid Corporation11822-0009
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralRite Aid Corporation11822-0124
Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralKroger Company30142-124
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralKroger Company30142-190
nicotineNicotine 4 mg/1LozengeOralH E B37808-383
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralMeijer Distribution Inc41250-190
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralMeijer Distribution Inc41250-700
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-190
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralPublix Super Markets Inc56062-499
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralPublix Super Markets Inc56062-509

Showing 20 of 28.

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