Prescription drug · ANDA
Cyproheptadine (Cyproheptadine hydrochloride) NDC 62135-949
Cyproheptadine hydrochloride 2 mg/5mL · Syrup · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-949-47 | 6213509494762135094947 | 473 mL in 1 BOTTLE (62135-949-47)Marketed from Jul 13, 2022 | |
| 62135-949-94 | 6213509499462135094994 | 946 mL in 1 BOTTLE (62135-949-94)Marketed from Jul 13, 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
- Generic name (nonproprietary)
- cyproheptadine hydrochloride
- Active ingredients
- Cyproheptadine hydrochloride — 2 mg/5mL
- Dosage form
- Syrup
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203191
- Marketing start
- Listing expires
- Identifiers
- Product ID 62135-949_06fd9a7b-3b04-6e0c-e063-6394a90aba46SPL ID 06fd9a7b-3b04-6e0c-e063-6394a90aba46SPL set ID 37fe7264-4d45-4d6c-ac13-40fcd1d82351RxCUI 866021UNII NJ82J0F8QCUPC 0362135949945
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
N462135094947followed by a unit qualifier and the quantityPackage 62135-0949-47. 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 62135-949
- What is NDC 62135-949?
- 62135-949 is the product NDC for Cyproheptadine (cyproheptadine hydrochloride), Cyproheptadine hydrochloride 2 mg/5mL syrup, listed with the FDA by Chartwell RX, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cyproheptadine (Cyproheptadine hydrochloride).
- What is the active ingredient?
- Cyproheptadine hydrochloride.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. 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?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.