Prescription drug · ANDA
Carbzah (carbinoxamine maleate) NDC 71085-080
Carbinoxamine maleate 4 mg/5mL · Solution · Oral · IPG Pharmaceuticals, inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71085-080-07 | 71085008007 | 473 mL in 1 BOTTLE, PLASTIC (71085-080-07)Marketed from Jun 1, 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)
- Carbzah
- Generic name (nonproprietary)
- carbinoxamine maleate
- Active ingredients
- Carbinoxamine maleate — 4 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- IPG Pharmaceuticals, inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040458
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71085-080_37b3e7c3-81ea-3a36-e063-6294a90a3d9fSPL ID 37b3e7c3-81ea-3a36-e063-6294a90a3d9fSPL set ID a845fc15-c675-4e33-840c-6a74e79d0cedRxCUI 1010696, 2730039UNII 02O55696WH
- 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
N471085008007followed by a unit qualifier and the quantityPackage 71085-0080-07. 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.
Other NDCs under ANDA 040458
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 4 mg/5mL | SolutionOral | Genus Lifesciences Inc. | 64950-243 |