What is NDC 71085-081?

71085-081 is the product NDC for Clemsza (clemastine fumarate), Clemastine fumarate 2.68 mg/1 tablet, listed with the FDA by IPG Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

IPG Pharmaceuticals, Inc., NDC labeler code 71085. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clemsza?

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.

Clemsza NDC 71085-081 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71085-081Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71085-0081Add 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
71085-081-30	7108500813071085008130	30 TABLET in 1 BOTTLE (71085-081-30)Marketed from Aug 1, 2025

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): Clemsza
Generic name (nonproprietary): clemastine fumarate
Active ingredients: Clemastine fumarate — 2.68 mg/1
Dosage form: Tablet
Route: Oral
Labeler: IPG Pharmaceuticals, Inc.NDC labeler code 71085
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 073283
Marketing start: Aug 1, 2025
Listing expires: Dec 31, 2027
Identifiers: Product ID 71085-081_5d1c62ed-2759-1ca8-e063-6294a90a6560SPL ID 5d1c62ed-2759-1ca8-e063-6294a90a6560

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

N471085008130 followed by a unit qualifier and the quantity

Package 71085-0081-30. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 71085-081

What is NDC 71085-081?: 71085-081 is the product NDC for Clemsza (clemastine fumarate), Clemastine fumarate 2.68 mg/1 tablet, listed with the FDA by IPG Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clemsza (Clemastine Fumarate).
What is the active ingredient?: Clemastine fumarate.
Who is the labeler?: IPG Pharmaceuticals, Inc., NDC labeler code 71085. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clemsza?: 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 073283

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

FDA NDC Directory listings under ANDA 073283
Product	Strength	Form · route	Labeler	Product NDC
Clemastine Fumarate	Clemastine fumarate 2.68 mg/1	TabletOral	Genus Lifesciences	64950-268

Clemsza (Clemastine fumarate) NDC 71085-081