NDC codes

FDA NDC Directory
Product NDC (as listed)68180-157Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68180-0157Add 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
68180-157-01681800157011 BOTTLE in 1 CARTON (68180-157-01) / 100 TABLET in 1 BOTTLEMarketed from May 8, 2019

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)
Clobazam
Generic name (nonproprietary)
clobazam
Active ingredients
Clobazam — 10 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210545
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)
Identifiers
Product ID 68180-157_ce8d2e9b-0cf3-4206-9523-6f0df27953b8SPL ID ce8d2e9b-0cf3-4206-9523-6f0df27953b8SPL set ID d9e03a2a-3fea-4c98-ab71-415e6ebda3e0RxCUI 199450, 246172UNII 2MRO291B4UUPC 0368180158011, 0368180157014
Pharmacologic class
Benzodiazepine

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

N468180015701 followed by a unit qualifier and the quantity

Package 68180-0157-01. 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)

Clobazam tablets are a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older ( 1 ) Clobazam tablets are indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210545

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

FDA NDC Directory listings under ANDA 210545
ProductStrengthForm · routeLabelerProduct NDC
ClobazamClobazam 20 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-158

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