Over-the-counter drug · ANDA
Nicotine (Nicotine polacrilex) NDC 51316-309
Nicotine 4 mg/1 · Gum, Chewing · Oral · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC codes
FDA NDC DirectoryProduct NDC (as listed)51316-309Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0309Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-309-10 | 5131603091051316030910 | 100 BLISTER PACK in 1 CARTON (51316-309-10) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from May 27, 2026 | |
| 51316-309-16 | 5131603091651316030916 | 160 BLISTER PACK in 1 CARTON (51316-309-16) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from May 28, 2026 | |
| 51316-309-20 | 5131603092051316030920 | 20 BLISTER PACK in 1 CARTON (51316-309-20) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 17, 2026 |
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
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNDC labeler code 51316
- 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 51316-309_378e01d2-9441-4727-b96c-276ca41d0c99SPL ID 378e01d2-9441-4727-b96c-276ca41d0c99SPL set ID ecf97d6b-6ca7-48c1-8c37-029421689cc1RxCUI 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
N451316030910followed by a unit qualifier and the quantityPackage 51316-0309-10. 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 51316-309
- What is NDC 51316-309?
- 51316-309 is the product NDC for Nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 3 package NDCs, 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?
- CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, NDC labeler code 51316. 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 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 |
|---|---|---|---|---|
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Amazon.com Services LLC | 72288-863 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreen Company | 0363-7103 |
| Berkley and Jensen Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | BJWC | 68391-309 |
| members mark nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Sam's West Inc | 68196-309 |
| Up And Up Coated Cinnamon Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-329 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Topco Associates LLC | 36800-650 |
| Up and Up Mint Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-500 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | H E B | 37808-611 |
| kirkland signature quit 4nicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Costco Wholesale Company | 63981-309 |
| up and up coated mint freeze nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Target Corporation | 82442-723 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Kroger Company | 30142-309 |
| Members Mark Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Sam's West Inc | 68196-971 |
| signature care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Safeway | 21130-173 |
| signature care nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Safeway | 21130-820 |
| 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 | H E B | 37808-683 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Publix Super Markets Inc | 56062-019 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Meijer Distribution Inc | 41250-510 |
| nicotine | Nicotine 4 mg/1 | Gum, ChewingOral | H E B | 37808-739 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-8600 |
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