Prescription drug · ANDA
Cyproheptadine Hydrochloride NDC 39328-544
Cyproheptadine 2 mg/5mL · Solution · Oral · Patrin Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 39328-544-16 | 39328054416 | 473 mL in 1 BOTTLE, GLASS (39328-544-16)Marketed from Feb 15, 2022 |
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)
- Cyproheptadine Hydrochloride
- Generic name (nonproprietary)
- cyproheptadine hydrochloride
- Active ingredients
- Cyproheptadine — 2 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Patrin Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209108
- Marketing start
- Listing expires
- Identifiers
- Product ID 39328-544_fcdc36f7-1523-46dc-a976-c3d150fae843SPL ID fcdc36f7-1523-46dc-a976-c3d150fae843SPL set ID 81d9523f-f945-4410-8b71-8b5fea48a3daRxCUI 866021UNII 2YHB6175DO
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
N439328054416followed by a unit qualifier and the quantityPackage 39328-0544-16. 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 Cold urticaria Dermatographism 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 209108
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 |
|---|---|---|---|---|
| cyproheptadine hydrochloride solutioncyproheptadine hydrochloride | Cyproheptadine 2 mg/5mL | SolutionOral | Method Pharmaceuticals, LLC | 58657-697 |