Over-the-counter drug · ANDA
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint (Nicotine polacrilex) NDC 75907-303
Nicotine 4 mg/1 · Gum, Chewing · Oral · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-303-10 | 7590703031075907030310 | 10 GUM, CHEWING in 1 BLISTER PACK (75907-303-10)Marketed from Jun 12, 2025 | |
| 75907-303-15 | 7590703031575907030315 | 15 BLISTER PACK in 1 CARTON (75907-303-15) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 12, 2025 | |
| 75907-303-80 | 7590703038075907030380 | 8 BLISTER PACK in 1 CARTON (75907-303-80) / 10 GUM, CHEWING in 1 BLISTER PACKMarketed from Jun 12, 2025 |
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)
- Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint
- Generic name (nonproprietary)
- nicotine polacrilex
- Active ingredients
- Nicotine — 4 mg/1
- Dosage form
- Gum, Chewing
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories Inc.NDC labeler code 75907
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078697
- Marketing start
- Listing expires
- Other FDA classes
- Nicotine (Chemical structure)
- Identifiers
- Product ID 75907-303_6dec3f9c-5e70-4992-aae4-822d470312a5SPL ID 6dec3f9c-5e70-4992-aae4-822d470312a5SPL set ID ed5722d7-746b-468e-89b5-506055d12bbdRxCUI 311975, 2717264UNII 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
N475907030310followed by a unit qualifier and the quantityPackage 75907-0303-10. 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 75907-303
- What is NDC 75907-303?
- 75907-303 is the product NDC for Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint, Nicotine 4 mg/1 gum, chewing, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint (Nicotine Polacrilex).
- What is the active ingredient?
- Nicotine.
- Who is the labeler?
- Dr. Reddy's Laboratories Inc., NDC labeler code 75907. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 078697
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, ChewingBuccal | Rugby Laboratories | 0536-3113 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Walgreens | 0363-9330 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 46122-718 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | A-S Medication Solutions | 50090-8146 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | AAFES/Your Military Exchanges | 55301-429 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-796 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-976 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Rising Pharma Holdings, Inc. | 57237-323 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Lucy Goods, Inc. | 72224-933 |
| Nicotine Polacrilex | Nicotine 4 mg/1 | Gum, ChewingOral | Quitine LLC | 84720-933 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Publix Supermarkets, Inc. | 56062-429 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-281 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-285 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | Chain Drug Consortium, LLC | 68016-560 |
| Nicotine Polacrilex coated mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CVS Pharmacy | 69842-430 |
| Nicotine Polacrilex Coated Mintnicotine polacrilex | Nicotine 4 mg/1 | Gum, ChewingBuccal | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | 70000-0343 |