Tetrabenazine NDC 43598-395

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-395Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0395Add 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
43598-395-05	43598039505	500 TABLET in 1 BOTTLE (43598-395-05)Marketed from Jan 8, 2018
43598-395-67	43598039567	112 TABLET in 1 BOTTLE (43598-395-67)Marketed from Jan 8, 2018

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): Tetrabenazine
Generic name (nonproprietary): tetrabenazine
Active ingredients: Tetrabenazine — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddys Laboratories Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209284
Marketing start: Jan 8, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 43598-395_b3ddb23f-3cc7-7c18-982b-970f7acc8766SPL ID b3ddb23f-3cc7-7c18-982b-970f7acc8766SPL set ID ef5f9dd4-945f-ec27-518d-90996a7bd4b6RxCUI 199592, 805464UNII Z9O08YRN8OUPC 0343598395678, 0343598394671
Pharmacologic class: Vesicular Monoamine Transporter 2 Inhibitor

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

N443598039505 followed by a unit qualifier and the quantity

Package 43598-0395-05. 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 Jan 30, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington’s disease. Tetrabenazine is a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntington’s disease. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209284

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

FDA NDC Directory listings under ANDA 209284
Product	Strength	Form · route	Labeler	Product NDC
Tetrabenazine	Tetrabenazine 12.5 mg/1	TabletOral	Dr. Reddys Laboratories Inc	43598-394