Clemastine Fumarate NDC 64950-324

NDC codes

FDA NDC Directory

Product NDC (as listed)64950-324Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64950-0324Add 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
64950-324-12	64950032412	120 mL in 1 BOTTLE (64950-324-12)Marketed from Nov 22, 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): Clemastine Fumarate
Generic name (nonproprietary): clemastine fumarate
Active ingredients: Clemastine fumarate — .67 mg/5mL
Dosage form: Syrup
Route: Oral
Labeler: Genus Lifesciences
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 073399
Marketing start: Nov 22, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 64950-324_1c00b77a-2510-443b-9ecc-dc6f953b50b0SPL ID 1c00b77a-2510-443b-9ecc-dc6f953b50b0SPL set ID 5c99e7af-86a5-4c17-82d5-2d4119e4fe72RxCUI 857430UNII 19259EGQ3D

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

N464950032412 followed by a unit qualifier and the quantity

Package 64950-0324-12. 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 Nov 25, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION ). It should be noted that clemastine is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.

Excerpt only. Read the full label for complete information.

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