What is NDC 39328-544?

39328-544 is the product NDC for Cyproheptadine Hydrochloride, Cyproheptadine 2 mg/5mL solution, listed with the FDA by Patrin Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Patrin Pharma, Inc., NDC labeler code 39328. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cyproheptadine Hydrochloride NDC 39328-544

NDC codes

FDA NDC Directory

Product NDC (as listed)39328-544Labeler and product segments. Claims need a package NDC.

Product NDC at billing width39328-0544Add 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
39328-544-16	3932805441639328054416	473 mL in 1 BOTTLE, GLASS (39328-544-16)Marketed from Feb 15, 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 Hydrochloride
Generic name (nonproprietary): cyproheptadine hydrochloride
Active ingredients: Cyproheptadine — 2 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Patrin Pharma, Inc.NDC labeler code 39328
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209108
Marketing start: Feb 15, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 39328-544_fcdc36f7-1523-46dc-a976-c3d150fae843SPL ID fcdc36f7-1523-46dc-a976-c3d150fae843SPL set ID 81d9523f-f945-4410-8b71-8b5fea48a3daRxCUI 866021UNII 2YHB6175DO

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

N439328054416 followed by a unit qualifier and the quantity

Package 39328-0544-16. 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 Feb 24, 2022.

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 39328-544

What is NDC 39328-544?: 39328-544 is the product NDC for Cyproheptadine Hydrochloride, Cyproheptadine 2 mg/5mL solution, listed with the FDA by Patrin Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cyproheptadine Hydrochloride.
What is the active ingredient?: Cyproheptadine.
Who is the labeler?: Patrin Pharma, Inc., NDC labeler code 39328. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cyproheptadine Hydrochloride NDCs
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 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

All 35 Cyproheptadine Hydrochloride NDCs

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 solutioncyproheptadine hydrochloride	Cyproheptadine 2 mg/5mL	SolutionOral	Method Pharmaceuticals, LLC	58657-697