What is NDC 31722-822?

31722-822 is the product NDC for Tetrabenazine, Tetrabenazine 25 mg/1 tablet, coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tetrabenazine?

21 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tetrabenazine NDC 31722-822 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-822Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0822Add 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
31722-822-11	3172208221131722082211	112 TABLET, COATED in 1 BOTTLE (31722-822-11)Marketed from Aug 17, 2015
31722-822-31	3172208223131722082231	10 TABLET, COATED in 1 BLISTER PACK (31722-822-31)Marketed from Aug 17, 2015
31722-822-32	3172208223231722082232	100 TABLET, COATED in 1 CARTON (31722-822-32)Marketed from Aug 17, 2015
31722-822-56	3172208225631722082256	56 TABLET, COATED in 1 BOTTLE (31722-822-56)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 — 25 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204574
Marketing start: Aug 17, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 31722-822_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

N431722082211 followed by a unit qualifier and the quantity

Package 31722-0822-11. 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)

About NDC 31722-822

What is NDC 31722-822?: 31722-822 is the product NDC for Tetrabenazine, Tetrabenazine 25 mg/1 tablet, coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tetrabenazine.
What is the active ingredient?: Tetrabenazine.
Who is the labeler?: Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tetrabenazine?: 21 other product NDCs are listed under this name. See all Tetrabenazine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tetrabenazine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tetrabenazine	Tetrabenazine 12.5 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-938	23155-0938-63
Tetrabenazine	Tetrabenazine 25 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-939	23155-0939-63
Tetrabenazine	Tetrabenazine 25 mg/1	TabletOral	Precision Dose Inc.	68094-805	68094-0805-10
Tetrabenazine	Tetrabenazine 12.5 mg/1	TabletOral	Precision Dose Inc.	68094-905	68094-0905-10
Tetrabenazine	Tetrabenazine 12.5 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-176	27241-0176-13
Tetrabenazine	Tetrabenazine 25 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-177	27241-0177-13
Tetrabenazine	Tetrabenazine 12.5 mg/1	TabletOral	Apotex Corp.	60505-3882	60505-3882-07
Tetrabenazine	Tetrabenazine 25 mg/1	TabletOral	Apotex Corp.	60505-3883	60505-3883-07
Tetrabenazine	Tetrabenazine 12.5 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-480	51407-0480-12
Tetrabenazine	Tetrabenazine 25 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-481	51407-0481-12

All 22 Tetrabenazine NDCs

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 12.5 mg/1	Tablet, CoatedOral	Camber Pharmaceuticals, Inc.	31722-821