Prescription drug · ANDA
Carbinoxamine Maleate NDC 80705-120
Carbinoxamine maleate 6 mg/1 · Tablet · Oral · TRIPOINT THERAPEUTICS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80705-120-30 | 8070501203080705012030 | 30 TABLET in 1 BOTTLE (80705-120-30)Marketed from Jul 22, 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)
- Carbinoxamine Maleate
- Generic name (nonproprietary)
- carbinoxamine maleate
- Active ingredients
- Carbinoxamine maleate — 6 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TRIPOINT THERAPEUTICS, LLCNDC labeler code 80705
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215476
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 80705-120_28237aea-8a3c-40ca-b2a1-0b7248ce5b99SPL ID 28237aea-8a3c-40ca-b2a1-0b7248ce5b99SPL set ID 91ee2e99-082a-4157-b71b-1a7c0e5464faRxCUI 1795581UNII 02O55696WHUPC 0380705120303
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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
N480705012030followed by a unit qualifier and the quantityPackage 80705-0120-30. 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)
INDICATIONS AND USAGE Carbinoxamine maleate is effective for the symptomatic treatment of: Seasonal and perennial allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Amelioration of the severity of allergic reactions to blood or plasma.
Excerpt only. Read the full label for complete information.
About NDC 80705-120
- What is NDC 80705-120?
- 80705-120 is the product NDC for Carbinoxamine Maleate, Carbinoxamine maleate 6 mg/1 tablet, listed with the FDA by TRIPOINT THERAPEUTICS, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carbinoxamine Maleate.
- What is the active ingredient?
- Carbinoxamine maleate.
- Who is the labeler?
- TRIPOINT THERAPEUTICS, LLC, NDC labeler code 80705. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Carbinoxamine Maleate?
- 5 other product NDCs are listed under this name. See all Carbinoxamine Maleate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Carbinoxamine Maleate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Carbinoxamine Maleate | Carbinoxamine maleate 6 mg/1 | TabletOral | Leading Pharma, LLC | 69315-239 | 69315-0239-01 |
| Carbinoxamine Maleate | Carbinoxamine maleate 6 mg/1 | TabletOral | BluCrest Pharmaceuticals, LLC | 73684-110 | 73684-0110-60 |
| Carbinoxamine Maleate | Carbinoxamine maleate 4 mg/1 | TabletOral | Genus Lifesciences Inc. | 64950-211 | 64950-0211-01 |
| Carbinoxamine Maleate | Carbinoxamine maleate 4 mg/5mL | SolutionOral | Genus Lifesciences Inc. | 64950-243 | 64950-0243-0464950-0243-16 |
| Carbinoxamine Maleate | Carbinoxamine maleate 4 mg/1 | TabletOral | Biocomp Pharma, Inc. | 44523-825 | 44523-0825-01 |
Other NDCs under ANDA 215476
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 |
|---|---|---|---|---|
| Carbinoxamine Maleate | Carbinoxamine maleate 6 mg/1 | TabletOral | Leading Pharma, LLC | 69315-239 |