What is NDC 68094-805?

68094-805 is the product NDC for Tetrabenazine, Tetrabenazine 25 mg/1 tablet, listed with the FDA by Precision Dose Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Precision Dose Inc., NDC labeler code 68094. 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 68094-805 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68094-805Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68094-0805Add 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
68094-805-10	6809408051068094080510	112 TABLET in 1 BOTTLE, PLASTIC (68094-805-10)Marketed from Dec 1, 2023

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: Precision Dose Inc.NDC labeler code 68094
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207682
Marketing start: Dec 1, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 68094-805_aca55884-1eb4-4a76-8c7f-96c782849337SPL ID aca55884-1eb4-4a76-8c7f-96c782849337SPL set ID aca55884-1eb4-4a76-8c7f-96c782849337RxCUI 199592, 805464UNII Z9O08YRN8OUPC 0368094805100, 0368094905107
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

N468094080510 followed by a unit qualifier and the quantity

Package 68094-0805-10. 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 Aug 31, 2023. 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)

About NDC 68094-805

What is NDC 68094-805?: 68094-805 is the product NDC for Tetrabenazine, Tetrabenazine 25 mg/1 tablet, listed with the FDA by Precision Dose Inc.. It has 1 package NDC, 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?: Precision Dose Inc., NDC labeler code 68094. 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 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
tetrabenazine	Tetrabenazine 12.5 mg/1	TabletOral	Slate Run Pharmaceuticals, LLC	70436-101	70436-0101-09

All 22 Tetrabenazine NDCs

Other NDCs under ANDA 207682

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

FDA NDC Directory listings under ANDA 207682
Product	Strength	Form · route	Labeler	Product NDC
Tetrabenazine	Tetrabenazine 12.5 mg/1	TabletOral	Precision Dose Inc.	68094-905