NDC codes

FDA NDC Directory
Product NDC (as listed)68094-905Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68094-0905Add 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 NDC11-digit (billing)PackageCopy
68094-905-106809409051068094090510112 TABLET in 1 BOTTLE, PLASTIC (68094-905-10)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 — 12.5 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
Listing expires
Other FDA classes
Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
Identifiers
Product ID 68094-905_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

N468094090510 followed by a unit qualifier and the quantity

Package 68094-0905-10. 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 . 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 68094-905

What is NDC 68094-905?
68094-905 is the product NDC for Tetrabenazine, Tetrabenazine 12.5 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TetrabenazineTetrabenazine 12.5 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-93823155-0938-63
TetrabenazineTetrabenazine 25 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-93923155-0939-63
TetrabenazineTetrabenazine 25 mg/1TabletOralPrecision Dose Inc.68094-80568094-0805-10
TetrabenazineTetrabenazine 12.5 mg/1TabletOralAjanta Pharma USA Inc.27241-17627241-0176-13
TetrabenazineTetrabenazine 25 mg/1TabletOralAjanta Pharma USA Inc.27241-17727241-0177-13
TetrabenazineTetrabenazine 12.5 mg/1TabletOralApotex Corp.60505-388260505-3882-07
TetrabenazineTetrabenazine 25 mg/1TabletOralApotex Corp.60505-388360505-3883-07
TetrabenazineTetrabenazine 12.5 mg/1TabletOralGolden State Medical Supply, Inc.51407-48051407-0480-12
TetrabenazineTetrabenazine 25 mg/1TabletOralGolden State Medical Supply, Inc.51407-48151407-0481-12
tetrabenazineTetrabenazine 12.5 mg/1TabletOralSlate Run Pharmaceuticals, LLC70436-10170436-0101-09

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
ProductStrengthForm · routeLabelerProduct NDC
TetrabenazineTetrabenazine 25 mg/1TabletOralPrecision Dose Inc.68094-805

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