Prescription drug · ANDA
Cyproheptadine Hydrochloride NDC 52817-415
Cyproheptadine hydrochloride 4 mg/1 · Tablet · Oral · TRUPHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-415-10 | 5281704151052817041510 | 100 TABLET in 1 BOTTLE, PLASTIC (52817-415-10)Marketed from Jun 1, 2026 | |
| 52817-415-50 | 5281704155052817041550 | 500 TABLET in 1 BOTTLE, PLASTIC (52817-415-50)Marketed from Jun 1, 2026 |
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 hydrochloride — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TRUPHARMA, LLCNDC labeler code 52817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206553
- Marketing start
- Listing expires
- Identifiers
- Product ID 52817-415_1d668d93-8c9e-479e-ad8d-59656c8dec1bSPL ID 1d668d93-8c9e-479e-ad8d-59656c8dec1bSPL set ID 1d668d93-8c9e-479e-ad8d-59656c8dec1bRxCUI 866144UNII NJ82J0F8QCUPC 0352817415103, 0352817415509
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
N452817041510followed by a unit qualifier and the quantityPackage 52817-0415-10. 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.
About NDC 52817-415
- What is NDC 52817-415?
- 52817-415 is the product NDC for Cyproheptadine Hydrochloride, Cyproheptadine hydrochloride 4 mg/1 tablet, listed with the FDA by TRUPHARMA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyproheptadine Hydrochloride.
- What is the active ingredient?
- Cyproheptadine hydrochloride.
- Who is the labeler?
- TRUPHARMA, LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cyproheptadine Hydrochloride?
- 34 other product NDCs are listed under this name. See all Cyproheptadine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cyproheptadine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 2 mg/1 | TabletOral | PANGEA PHARMACEUTICALS, LLC | 81279-129 | 81279-0129-3081279-0129-60 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4667 | 70518-4667-00 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | AvPAK | 50268-201 | 50268-0201-15 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 2 mg/5mL | SolutionOral | Atlantic Biologicals Corp. | 17856-1185 | 17856-1185-0117856-1185-02 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 2 mg/5mL | SolutionOral | QUAGEN PHARMACEUTICALS LLC | 70752-185 | 70752-0185-12 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3517 | 70518-3517-00 |
| Cyproheptadine Hydrochloride | Cyproheptadine 2 mg/5mL | SolutionOral | Patrin Pharma, Inc. | 39328-544 | 39328-0544-16 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-805 | 16571-0805-0116571-0805-10 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 2 mg/5mL | SyrupOral | Tris Pharma Inc | 27808-099 | 27808-0099-01 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | QPharma Inc | 42708-187 | 42708-0187-21 |
Other NDCs under ANDA 206553
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 | 42708-177 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-5491 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | TRUPHARMA, LLC | 52817-210 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0211 |