Prescription drug · ANDA
Ryclora (dexchlorpheniramine maleate) NDC 15370-150
Dexchlorpheniramine maleate 2 mg/5mL · Liquid · Oral · CARWIN PHARMACEUTICAL ASSOCIATES, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15370-150-04 | 15370015004 | 118 mL in 1 BOTTLE, PLASTIC (15370-150-04)Marketed from Oct 7, 2018 | |
| 15370-150-16 | 15370015016 | 473 mL in 1 BOTTLE, PLASTIC (15370-150-16)Marketed from Oct 7, 2018 | |
| 15370-150-99 | 15370015099 | 20 mL in 1 BOTTLE, PLASTIC (15370-150-99)Marketed from Oct 7, 2018 |
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)
- Ryclora
- Generic name (nonproprietary)
- dexchlorpheniramine maleate
- Active ingredients
- Dexchlorpheniramine maleate — 2 mg/5mL
- Dosage form
- Liquid
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202520
- Marketing start
- Listing expires
- Identifiers
- Product ID 15370-150_3affdd03-252d-443c-9966-e3aec314fb98SPL ID 3affdd03-252d-443c-9966-e3aec314fb98SPL set ID aa4f80c9-e600-4bc0-8528-02a8162a36f0RxCUI 2183907, 2183912UNII B10YD955QWUPC 0315370150164
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
N415370015004followed by a unit qualifier and the quantityPackage 15370-0150-04. 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 Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema Amelioration of allergic reactions to blood or plasma Dermographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202520
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 |
|---|---|---|---|---|
| Corphenadexchlorpheniramine maleate | Dexchlorpheniramine maleate 2 mg/5mL | SolutionOral | BluCrest Pharmaceuticals LLC | 73684-300 |