Clemastine Fumarate NDC 62135-713

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-713Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0713Add 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
62135-713-41	62135071341	120 mL in 1 BOTTLE (62135-713-41)Marketed from Jul 7, 2023

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: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074884
Marketing start: Dec 17, 1997
Listing expires: Dec 31, 2026
Identifiers: Product ID 62135-713_ffe63870-181f-e007-e053-6294a90a074eSPL ID ffe63870-181f-e007-e053-6294a90a074eSPL set ID 6663f1b0-5353-401f-b9d3-d9f69ad08fbfRxCUI 857430UNII 19259EGQ3DUPC 0362135713416

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

N462135071341 followed by a unit qualifier and the quantity

Package 62135-0713-41. 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 Jul 7, 2023.

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 fumarate 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)