Over-the-counter drug · ANDA
Nicotine Polacrilex original (Nicotine polacrilex) NDC 0363-1609
Nicotine 4 mg/1 · Gum, Chewing · Buccal · Walgreens
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0363-1609-62 | 0036316096200363160962 | 110 BLISTER PACK in 1 CARTON (0363-1609-62) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 | |
| 0363-1609-98 | 0036316099800363160998 | 170 BLISTER PACK in 1 CARTON (0363-1609-98) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Jan 1, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Buccal
- Labeler
- WalgreensNDC labeler code 0363
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074707
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0363-1609_ce202975-a51b-43ae-aec6-d64f38f1be16SPL ID ce202975-a51b-43ae-aec6-d64f38f1be16SPL set ID f759d9b2-35e0-4b88-9219-4c0e483af5c4RxCUI 311975, 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. Buccal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400363160962followed by a unit qualifier and the quantityPackage 00363-1609-62. 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 0363-1609
- What is NDC 0363-1609?
- 0363-1609 is the product NDC for Nicotine Polacrilex original (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Walgreens. It has 2 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?
- Walgreens, NDC labeler code 0363. 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 2 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-608 | 69842-0608-1569842-0608-5069842-0608-79+1 more |
| 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 074707
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 | Walgreens | 0363-9350 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Rugby Laboratories | 0536-3030 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | The Kroger Co. | 30142-671 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-733 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | P & L Development, LLC | 59726-935 |
| Nicotine Polacrilex Origianl Flavornicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-609 |
| Nicotine Polacrilex originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-609 |
| Nicotine Polacrilex Originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0341 |
| Nicotine Polacrilex, Originalnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-287 |
| Rugby Nicotine Polacrilex Gum, Original Flavornicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | ATLANTIC BIOLOGICALS CORP. | 17856-3030 |