Prescription drug · NDA AUTHORIZED GENERIC
Carbinoxamine Maleate Extended-Release Oral Suspension (Carbinoxamine maleate) NDC 62542-101
Carbinoxamine maleate 4 mg/5mL · Suspension, Extended release · Oral · Neos Therapeutics, LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62542-101-05 | 6254201010562542010105 | 480 mL in 1 BOTTLE, PLASTIC (62542-101-05)Marketed from Jun 1, 2024 |
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 Extended-Release Oral Suspension
- Generic name (nonproprietary)
- carbinoxamine maleate
- Active ingredients
- Carbinoxamine maleate — 4 mg/5mL
- Dosage form
- Suspension, Extended release
- Route
- Oral
- Labeler
- Neos Therapeutics, LPNDC labeler code 62542
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022556
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62542-101_4cdb19d3-49f4-c257-e063-6294a90aaabdSPL ID 4cdb19d3-49f4-c257-e063-6294a90aaabdSPL set ID 199f46e5-6288-5627-e063-6294a90ae086RxCUI 1374770UNII 02O55696WHUPC 0323594101053
- 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
N462542010105followed by a unit qualifier and the quantityPackage 62542-0101-05. 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)
Carbinoxamine Maleate extended-release oral suspension is indicated for adults and pediatric patients 2 years of age and older 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 Carbinoxamine Maleate extended-release oral suspension is an H1 receptor antagonist indicated for adults and ped…
Excerpt only. Read the full label for complete information.
About NDC 62542-101
- What is NDC 62542-101?
- 62542-101 is the product NDC for Carbinoxamine Maleate Extended-Release Oral Suspension, Carbinoxamine maleate 4 mg/5mL suspension, extended release, listed with the FDA by Neos Therapeutics, LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carbinoxamine Maleate Extended-Release Oral Suspension (Carbinoxamine Maleate).
- What is the active ingredient?
- Carbinoxamine maleate.
- Who is the labeler?
- Neos Therapeutics, LP, NDC labeler code 62542. 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 Extended-Release Oral Suspension?
- 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 NDA 022556
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 |
|---|---|---|---|---|
| Karbinal ERcarbinoxamine maleate | Carbinoxamine maleate 4 mg/5mL | Suspension, Extended releaseOral | Aytu Therapeutics, LLC | 23594-101 |