Prescription drug · ANDA
Carbinoxamine Maleate NDC 44523-825
Carbinoxamine maleate 4 mg/1 · Tablet · Oral · Biocomp Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44523-825-01 | 4452308250144523082501 | 1 BOTTLE in 1 CARTON (44523-825-01) / 100 TABLET in 1 BOTTLEMarketed from Jun 28, 2021 |
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 — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Biocomp Pharma, Inc.NDC labeler code 44523
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090756
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 44523-825_462c3a74-f82a-4fda-e063-6294a90ab0a7SPL ID 462c3a74-f82a-4fda-e063-6294a90ab0a7SPL set ID 14266e97-674b-b6a9-37a2-a955f0a01c4fRxCUI 1012904UNII 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
N444523082501followed by a unit qualifier and the quantityPackage 44523-0825-01. 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 angio-edema. 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 44523-825
- What is NDC 44523-825?
- 44523-825 is the product NDC for Carbinoxamine Maleate, Carbinoxamine maleate 4 mg/1 tablet, listed with the FDA by Biocomp Pharma, Inc.. 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?
- Biocomp Pharma, Inc., NDC labeler code 44523. 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 | TRIPOINT THERAPEUTICS, LLC | 80705-120 | 80705-0120-30 |
| 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 |