Tetrabenazine NDC 31722-821

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-821Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0821Add 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
31722-821-11	31722082111	112 TABLET, COATED in 1 BOTTLE (31722-821-11)Marketed from Aug 17, 2015
31722-821-31	31722082131	10 TABLET, COATED in 1 BLISTER PACK (31722-821-31)Marketed from Aug 17, 2015
31722-821-32	31722082132	100 TABLET, COATED in 1 CARTON (31722-821-32)Marketed from Aug 17, 2015
31722-821-56	31722082156	56 TABLET, COATED in 1 BOTTLE (31722-821-56)Marketed from Aug 17, 2015

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, Coated
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204574
Marketing start: Aug 17, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 31722-821_3a2ffa8c-f4c5-47e2-8775-5d0edfa55658SPL ID 3a2ffa8c-f4c5-47e2-8775-5d0edfa55658SPL set ID a03c3cf8-fcd4-4dbf-a4f5-59bd7887c902RxCUI 199592, 805464UNII Z9O08YRN8OUPC 0331722822114
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

N431722082111 followed by a unit qualifier and the quantity

Package 31722-0821-11. 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 16, 2018. 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 tablet 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 204574

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

FDA NDC Directory listings under ANDA 204574
Product	Strength	Form · route	Labeler	Product NDC
Tetrabenazine	Tetrabenazine 25 mg/1	Tablet, CoatedOral	Camber Pharmaceuticals, Inc.	31722-822