Prescription drug · ANDA
Cyproheptadine Hydrochloride NDC 70518-3517
Cyproheptadine hydrochloride 4 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3517-0 | 70518351700 | 30 TABLET in 1 BLISTER PACK (70518-3517-0)Marketed from Sep 13, 2022 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hydrochloride — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212491
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-3517_4f1ffe50-29f4-fe99-e063-6294a90a2cebSPL ID 4f1ffe50-29f4-fe99-e063-6294a90a2cebSPL set ID 7b3aed50-cc9e-4897-9735-361225e9e5f2RxCUI 866144UNII NJ82J0F8QC
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
N470518351700followed by a unit qualifier and the quantityPackage 70518-3517-00. 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 212491
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 | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | QPharma Inc | 42708-187 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2453 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2964 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2066 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | QUAGEN PHARMACEUTICALS LLC | 70752-107 |