Over-the-counter drug · ANDA
Nicotine (nicotine polacrilex) NDC 51316-190
Nicotine 4 mg/1 · Lozenge · Oral · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-190-10 | 51316019010 | 4 CONTAINER in 1 CARTON (51316-190-10) / 27 LOZENGE in 1 CONTAINER (51316-190-09)Marketed from Jun 19, 2024 |
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
- Lozenge
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090711
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 51316-190_6e653b9b-5e39-4a91-bdea-3da5ee7ef0a2SPL ID 6e653b9b-5e39-4a91-bdea-3da5ee7ef0a2SPL set ID 114418c4-6f39-46ce-912c-ac3687b7b75eRxCUI 359818UNII 6M3C89ZY6RUPC 0012345678905
- 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
N451316019010followed by a unit qualifier and the quantityPackage 51316-0190-10. 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.
Other NDCs under ANDA 090711
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 |
|---|---|---|---|---|
| nicotine | Nicotine 4 mg/1 | LozengeOral | H E B | 37808-383 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Walgreen Company | 0363-4190 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-700 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Rite Aid Corporation | 11822-0124 |
| Topcare Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Topco Associates LLC | 36800-539 |
| Kirkland Signature Nicotinenicotine | Nicotine 4 mg/1 | LozengeOral | Costco Wholesale Company | 63981-190 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Kroger Company | 30142-124 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Meijer Distribution Inc | 41250-190 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | CVS Pharmacy | 59779-397 |
| Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-771 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-124 |
| Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Kroger Company | 30142-190 |
| Basic Care Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-190 |
| nicotine | Nicotine 2 mg/1 | LozengeOral | H E B | 37808-533 |
| equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-124 |
| Equate Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-190 |
| Kirkland Signature Nicotinenicotine | Nicotine 2 mg/1 | LozengeOral | Costco Wholesale Company | 63981-124 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-1125 |
| nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Publix Super Markets Inc | 56062-499 |
| nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Publix Super Markets Inc | 56062-509 |
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