What is NDC 64950-324?

64950-324 is the product NDC for Clemastine Fumarate, Clemastine fumarate .67 mg/5mL syrup, listed with the FDA by Genus Lifesciences. It has 1 package NDC, shown above in 10- and 11-digit form.

Genus Lifesciences, NDC labeler code 64950. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clemastine Fumarate?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clemastine Fumarate NDC 64950-324 | National Drug Code

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	6495003241264950032412	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 LifesciencesNDC labeler code 64950
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.

Full label on DailyMed (opens in a new tab)

About NDC 64950-324

What is NDC 64950-324?: 64950-324 is the product NDC for Clemastine Fumarate, Clemastine fumarate .67 mg/5mL syrup, listed with the FDA by Genus Lifesciences. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clemastine Fumarate.
What is the active ingredient?: Clemastine fumarate.
Who is the labeler?: Genus Lifesciences, NDC labeler code 64950. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clemastine Fumarate?: 2 other product NDCs are listed under this name. See all Clemastine Fumarate 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 Clemastine Fumarate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clemastine Fumarate	Clemastine fumarate 2.68 mg/1	TabletOral	Genus Lifesciences	64950-268	64950-0268-0364950-0268-10
Clemastine Fumarate	Clemastine fumarate .67 mg/5mL	SyrupOral	Chartwell RX, LLC	62135-713	62135-0713-41