tetrabenazine NDC 70436-101

NDC codes

FDA NDC Directory

Product NDC (as listed)70436-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70436-0101Add 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
70436-101-09	70436010109	112 TABLET in 1 BOTTLE (70436-101-09)Marketed from Mar 2, 2020

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 — 12.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Slate Run Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213316
Marketing start: Mar 2, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 70436-101_de4c0693-1b76-4026-bd94-a7a5dcc8a376SPL ID de4c0693-1b76-4026-bd94-a7a5dcc8a376SPL set ID 49587379-1cc0-48ff-9f2f-517079cf499dRxCUI 199592, 805464UNII Z9O08YRN8OUPC 0370436102099, 0370436101092
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

N470436010109 followed by a unit qualifier and the quantity

Package 70436-0101-09. 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 Oct 22, 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 tablets are 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 213316

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

FDA NDC Directory listings under ANDA 213316
Product	Strength	Form · route	Labeler	Product NDC
tetrabenazine	Tetrabenazine 25 mg/1	TabletOral	Slate Run Pharmaceuticals, LLC	70436-102
Tetrabenazine	Tetrabenazine 12.5 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-938
Tetrabenazine	Tetrabenazine 25 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-939