What is NDC 58657-697?

58657-697 is the product NDC for cyproheptadine hydrochloride solution, Cyproheptadine 2 mg/5mL solution, listed with the FDA by Method Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

cyproheptadine hydrochloride solution (Cyproheptadine hydrochloride).

Method Pharmaceuticals, LLC, NDC labeler code 58657. 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 solution?

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.

cyproheptadine hydrochloride solution NDC 58657-697

NDC codes

FDA NDC Directory

Product NDC (as listed)58657-697Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58657-0697Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
58657-697-16	5865706971658657069716	473 mL in 1 BOTTLE, GLASS (58657-697-16)Marketed from Jun 15, 2024

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 solution
Generic name (nonproprietary): cyproheptadine hydrochloride
Active ingredients: Cyproheptadine — 2 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Method Pharmaceuticals, LLCNDC labeler code 58657
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209108
Marketing start: Jun 15, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 58657-697_41b48ab2-962e-790a-e063-6394a90a6106SPL ID 41b48ab2-962e-790a-e063-6394a90a6106SPL set ID 1acfd050-6c07-a269-e063-6394a90a77e8RxCUI 866021UNII 2YHB6175DOUPC 0358657697167

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

N458657069716 followed by a unit qualifier and the quantity

Package 58657-0697-16. 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 Oct 21, 2025.

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.

Full label on DailyMed (opens in a new tab)

About NDC 58657-697

What is NDC 58657-697?: 58657-697 is the product NDC for cyproheptadine hydrochloride solution, Cyproheptadine 2 mg/5mL solution, listed with the FDA by Method Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: cyproheptadine hydrochloride solution (Cyproheptadine hydrochloride).
What is the active ingredient?: Cyproheptadine.
Who is the labeler?: Method Pharmaceuticals, LLC, NDC labeler code 58657. 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 solution?: 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.

Other NDCs under ANDA 209108

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209108
Product	Strength	Form · route	Labeler	Product NDC
Cyproheptadine Hydrochloride	Cyproheptadine 2 mg/5mL	SolutionOral	Patrin Pharma, Inc.	39328-544

cyproheptadine hydrochloride solution (Cyproheptadine hydrochloride) NDC 58657-697