NDC codes

FDA NDC Directory
Product NDC (as listed)51407-481Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0481Add 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
51407-481-1251407048112112 TABLET in 1 BOTTLE (51407-481-12)Marketed from Jul 26, 2021

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
Tetrabenazine25 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206093
Marketing start
Listing expires
Other FDA classes
Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
Identifiers
Product ID 51407-481_410f7183-66d2-9ae2-e063-6394a90ac256SPL ID 410f7183-66d2-9ae2-e063-6394a90ac256SPL set ID cbfb791e-26ac-9fb5-e053-2995a90ac7e5RxCUI 199592, 805464UNII Z9O08YRN8O
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

N451407048112 followed by a unit qualifier and the quantity

Package 51407-0481-12. 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)

Other NDCs under ANDA 206093

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

FDA NDC Directory listings under ANDA 206093
ProductStrengthForm · routeLabelerProduct NDC
TetrabenazineTetrabenazine 12.5 mg/1TabletOralApotex Corp.60505-3882
TetrabenazineTetrabenazine 25 mg/1TabletOralApotex Corp.60505-3883
TetrabenazineTetrabenazine 12.5 mg/1TabletOralGolden State Medical Supply, Inc.51407-480

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