Over-the-counter drug · ANDA
Nicotine Polacrilex original (Nicotine polacrilex) NDC 69842-608
Nicotine 2 mg/1 · Gum, Chewing · Buccal · CVS Pharmacy
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69842-608-15 | 6984206081569842060815 | 20 BLISTER PACK in 1 CARTON (69842-608-15) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 | |
| 69842-608-50 | 6984206085069842060850 | 50 BLISTER PACK in 1 CARTON (69842-608-50) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 | |
| 69842-608-79 | 6984206087969842060879 | 10 BLISTER PACK in 1 CARTON (69842-608-79) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 | |
| 69842-608-98 | 6984206089869842060898 | 170 BLISTER PACK in 1 CARTON (69842-608-98) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 |
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 Polacrilex originalSuffix: original
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 2 mg/1
- Dosage form
- Gum, Chewing
- Route
- Buccal
- Labeler
- CVS PharmacyNDC labeler code 69842
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074507
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 69842-608_0ab21cfd-645a-4c3a-b497-f77099ed1c9fSPL ID 0ab21cfd-645a-4c3a-b497-f77099ed1c9fSPL set ID 62231539-ae9f-4665-ba59-bef047e93d8aRxCUI 311975, 314119UNII 6M3C89ZY6RUPC 0050428335727, 0050428373798
- 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469842060815followed by a unit qualifier and the quantityPackage 69842-0608-15. 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 69842-608
- What is NDC 69842-608?
- 69842-608 is the product NDC for Nicotine Polacrilex original (nicotine polacrilex), Nicotine 2 mg/1 gum, chewing, listed with the FDA by CVS Pharmacy. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nicotine Polacrilex original (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- CVS Pharmacy, NDC labeler code 69842. 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 Polacrilex original?
- 7 other product NDCs are listed under this name. See all Nicotine Polacrilex original NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nicotine Polacrilex original products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicotine Polacrilex Originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0341 | 70000-0341-01 |
| Nicotine Polacrilex Originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0345 | 70000-0345-01 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreens | 0363-1608 | 00363-1608-6200363-1608-98 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Walgreens | 0363-1609 | 00363-1609-6200363-1609-98 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-609 | 69842-0609-1569842-0609-5069842-0609-79+1 more |
| Nicotine Polacrilex, Originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-286 | 68016-0286-62 |
| Nicotine Polacrilex, Originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-287 | 68016-0287-62 |
Other NDCs under ANDA 074507
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 2 mg/1 | Gum, ChewingOral | Walgreens | 0363-9290 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3029 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | The Kroger Co. | 30142-859 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-719 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | P & L Development, LLC | 59726-929 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | McKesson Corporation dba SKY Packaging | 63739-371 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | Walgreens | 0363-1608 |
| Nicotine Polacrilex Originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0345 |
| Nicotine Polacrilex Original Flavornicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-608 |
| Nicotine Polacrilex, Originalnicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-286 |