Over-the-counter drug · ANDA
nicotine NDC 37808-533
Nicotine 2 mg/1 · Lozenge · Oral · H E B
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37808-533-10 | 3780805331037808053310 | 4 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
N437808053310followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other nicotine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-684 | 72288-0684-02 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-730 | 72288-0730-60 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-755 | 72288-0755-06 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-863 | 72288-0863-06 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Safeway | 21130-772 | 21130-0772-02 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-969 | 72288-0969-76 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-869 | 72288-0869-76 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Cardinal Health 107, LLC | 55154-6818 | 55154-6818-00 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-651 | 72288-0651-14 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-2511 | 00363-2511-27 |
Other NDCs under ANDA 090711
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-124 |
| Basic Care Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-190 |
| equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-124 |
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-190 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-1125 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | L. Perrigo Company | 0113-1190 |
| Kirkland Signature Nicotinenicotine | Nicotine 2 mg/1 | LozengeOral | Costco Wholesale Company | 63981-124 |
| Kirkland Signature Nicotinenicotine | Nicotine 4 mg/1 | LozengeOral | Costco Wholesale Company | 63981-190 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Walgreen Company | 0363-0124 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreen Company | 0363-4190 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Rite Aid Corporation | 11822-0009 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rite Aid Corporation | 11822-0124 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Kroger Company | 30142-124 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Kroger Company | 30142-190 |
| nicotine | Nicotine 4 mg/1 | LozengeOral | H E B | 37808-383 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-190 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-700 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 51316-190 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Publix Super Markets Inc | 56062-499 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Publix Super Markets Inc | 56062-509 |
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