Over-the-counter drug · ANDA
Good Sense Nicotine (Nicotine polacrilex) NDC 0113-0957
Nicotine 4 mg/1 · Lozenge · Oral · L. Perrigo Company
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0113-0957Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00113-0957Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0113-0957-02 | 00113095702 | 3 CONTAINER in 1 CARTON (0113-0957-02) / 27 LOZENGE in 1 CONTAINER (0113-0957-01)Marketed from Apr 27, 2013 | |
| 0113-0957-04 | 00113095704 | 5 CONTAINER in 1 CARTON (0113-0957-04) / 27 LOZENGE in 1 CONTAINER (0113-0957-01)Marketed from Jun 21, 2024 | |
| 0113-0957-07 | 00113095707 | 8 CONTAINER in 1 CARTON (0113-0957-07) / 27 LOZENGE in 1 CONTAINER (0113-0957-01)Marketed from Jun 21, 2024 | |
| 0113-0957-27 | 00113095727 | 1 CONTAINER in 1 CARTON (0113-0957-27) / 27 LOZENGE in 1 CONTAINER (0113-0957-01)Marketed from Feb 26, 2026 | |
| 0113-0957-60 | 00113095760 | 1 CONTAINER in 1 CARTON (0113-0957-60) / 20 LOZENGE in 1 CONTAINERMarketed from Mar 27, 2018 |
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)
- Good Sense Nicotine
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Lozenge
- Route
- Oral
- Labeler
- L. Perrigo CompanyNDC labeler code 0113
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203690
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 0113-0957_5a643025-10d5-4251-84bf-9f1c168a8530SPL ID 5a643025-10d5-4251-84bf-9f1c168a8530SPL set ID 1a7cfbdc-53cc-4cd2-86b2-6e27a7979abfRxCUI 359818UNII 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
N400113095702followed by a unit qualifier and the quantityPackage 00113-0957-02. 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 0113-0957
- What is NDC 0113-0957?
- 0113-0957 is the product NDC for Good Sense Nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by L. Perrigo Company. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Good Sense Nicotine (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Good Sense Nicotine?
- 27 other product NDCs are listed under this name. See all Good Sense Nicotine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Good Sense 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) |
|---|---|---|---|---|---|
| good sense nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-6305 | 00113-6305-60 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-7969 | 00113-7969-01 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | L. Perrigo Company | 0113-7999 | 00113-7999-60 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-4111 | 00113-4111-06 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-7020 | 00113-7020-14 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | L. Perrigo Company | 0113-7031 | 00113-7031-14 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-6020 | 00113-6020-0600113-6020-60 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | L. Perrigo Company | 0113-5023 | 00113-5023-2700113-5023-6000113-5023-76 |
| Good Sense Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | L. Perrigo Company | 0113-2502 | 00113-2502-2700113-2502-6000113-2502-76 |
| good sense nicotinenicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | L. Perrigo Company | 0113-8600 | 00113-8600-0100113-8600-2500113-8600-29 |
Other NDCs under ANDA 203690
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 |
|---|---|---|---|---|
| Basic Care Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-077 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-223 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-642 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-734 |
| basic care nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-808 |
| basic care nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Amazon.com Services LLC | 72288-957 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | BJWC | 68391-734 |
| berkley and jensen nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | BJWC | 68391-957 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Blip Products, Inc. | 82966-222 |
| Blipnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Blip Products, Inc. | 82966-303 |
| Blipnicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Blip Products, Inc. | 82966-734 |
| Blipnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Blip Products, Inc. | 82966-957 |
| CareOne Mini Nicotine Polacrilexnicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | American Sales Company | 41520-957 |
| CareOne Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | American Sales Company | 41520-734 |
| Dg Health Nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Dolgencorp Inc | 55910-669 |
| Equate Nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-734 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-791 |
| Equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | Wal-Mart Stores Inc | 49035-900 |
| equate nicotinenicotine polacrilex | Nicotine 4 mg/1 | LozengeOral | WALMART INC. | 79903-104 |
| equate nicotinenicotine polacrilex | Nicotine 2 mg/1 | LozengeOral | WALMART INC. | 79903-160 |
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