Over-the-counter drug · ANDA
nicotine (Nicotine polacrilex) NDC 37808-683
Nicotine 4 mg/1 · Gum, Chewing · Oral · H E B
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37808-683-06 | 37808068306 | 160 BLISTER PACK in 1 CARTON (37808-683-06) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jul 1, 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 — 4 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 206393
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 37808-683_1cac1a6b-196c-4bf0-b58e-871fabf7df13SPL ID 1cac1a6b-196c-4bf0-b58e-871fabf7df13SPL set ID 9bf10dfc-c6df-4cc9-ba79-2dcf874a2904RxCUI 311975UNII 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
N437808068306followed by a unit qualifier and the quantityPackage 37808-0683-06. 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 37808-683
- What is NDC 37808-683?
- 37808-683 is the product NDC for nicotine (nicotine polacrilex), Nicotine 4 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?
- 194 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 | 72288-730 | 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 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Sixarp, LLC | 59368-463 | 59368-0463-02 |
Other NDCs under ANDA 206393
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 |
|---|---|---|---|---|
| Up And Up Coated Fruit Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-971 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer, Inc. | 79481-0601 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-7103 |
| Quitine Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | QUITINE LLC | 84720-309 |
| Members Mark Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Sam's West Inc | 68196-971 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-8600 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Padagis Israel Pharmaceuticals Ltd | 45802-651 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | A-S Medication Solutions | 50090-6674 |
| topcare nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-967 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-540 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | A-S Medication Solutions | 50090-6695 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-689 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-4111 |
| Basic Care Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-003 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-0053 |
| kirkland signature quit 4nicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-309 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-693 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Publix Super Markets Inc | 56062-019 |
| blipnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-971 |
| Blipnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Blip Products, Inc. | 82966-309 |
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