Over-the-counter drug · ANDA
nicotine (Nicotine polacrilex) NDC 37808-909
Nicotine 2 mg/1 · Gum, Chewing · Oral · H E B
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37808-909-06 | 37808090906 | 160 BLISTER PACK in 1 CARTON (37808-909-06) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 26, 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 polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- 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 206394
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 37808-909_38543770-5e28-4025-8977-957215504d81SPL ID 38543770-5e28-4025-8977-957215504d81SPL set ID a1f36614-539f-45db-aad4-1b300c60bf43RxCUI 314119UNII 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
N437808090906followed by a unit qualifier and the quantityPackage 37808-0909-06. 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 37808-909
- What is NDC 37808-909?
- 37808-909 is the product NDC for nicotine (nicotine polacrilex), Nicotine 2 mg/1 gum, chewing, 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?
- 196 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 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 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Sixarp, LLC | 59368-463 | 59368-0463-02 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-888 | 72288-0888-14 |
Other NDCs under ANDA 206394
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 |
|---|---|---|---|---|
| signature care nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Safeway | 21130-269 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-529 |
| members mark nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Sam's West Inc | 68196-269 |
| equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Wal-Mart Stores Inc | 49035-415 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-7269 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Meijer, Inc. | 79481-0755 |
| HEB Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | H E B | 37808-863 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Padagis Israel Pharmaceuticals Ltd | 45802-827 |
| good sense nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-8100 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | HyVee Inc | 42507-343 |
| Topcare Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-460 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-6020 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Kroger Company | 30142-749 |
| Kirkland Signature Quit 2nicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-012 |
| good sense nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | A-S Medication Solutions | 50090-7063 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-012 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-269 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Rite Aid Corporation | 11822-0269 |
| careone nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | American Sales Company | 41520-711 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-209 |
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