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 | 7108500800771085008007 | 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.NDC labeler code 71085
- 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_5d1c5c53-fa75-ac48-e063-6394a90a2a27SPL ID 5d1c5c53-fa75-ac48-e063-6394a90a2a27
- 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 71085-080
- What is NDC 71085-080?
- 71085-080 is the product NDC for Carbzah (carbinoxamine maleate), Carbinoxamine maleate 4 mg/5mL solution, listed with the FDA by IPG Pharmaceuticals, inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carbzah (Carbinoxamine Maleate).
- What is the active ingredient?
- Carbinoxamine maleate.
- Who is the labeler?
- IPG Pharmaceuticals, inc., NDC labeler code 71085. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Carbzah?
- 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 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 |