Prescription drug · ANDA
Cyproheptadine Hydrochloride NDC 0115-1757
Cyproheptadine hydrochloride 4 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1757-01 | 0011517570100115175701 | 100 TABLET in 1 BOTTLE, PLASTIC (0115-1757-01)Marketed from Jul 29, 2015 | |
| 0115-1757-03 | 0011517570300115175703 | 1000 TABLET in 1 BOTTLE, PLASTIC (0115-1757-03)Marketed from Jul 29, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040537
- Marketing start
- Listing expires
- Identifiers
- Product ID 0115-1757_f4a945a1-a20b-4b93-858a-856db91dd601SPL ID f4a945a1-a20b-4b93-858a-856db91dd601SPL set ID 80e13d3f-f4db-4bb4-95d5-5ac1afa70e7eRxCUI 866144UNII NJ82J0F8QCUPC 0301151757011
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
N400115175701followed by a unit qualifier and the quantityPackage 00115-1757-01. 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 0115-1757
- What is NDC 0115-1757?
- 0115-1757 is the product NDC for Cyproheptadine Hydrochloride, Cyproheptadine hydrochloride 4 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals of New York 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?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 | TRUPHARMA, LLC | 52817-415 | 52817-0415-1052817-0415-50 |
| 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 |
Other NDCs under ANDA 040537
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 | AvPAK | 50268-201 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4667 |
| Cyproheptadine Hydrochloride | Cyproheptadine hydrochloride 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2368 |