NDC codes

FDA NDC Directory
Product NDC (as listed)69238-1305Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-1305Add 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
69238-1305-16923813050169238130501100 TABLET in 1 BOTTLE (69238-1305-1)Marketed from Oct 22, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209718
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 69238-1305_182c75a8-797a-457e-915b-c3297e71b43bSPL ID 182c75a8-797a-457e-915b-c3297e71b43bSPL set ID 6783eaa8-e236-4957-aaa9-b42bf8e709a7RxCUI 199450, 246172UNII 2MRO291B4U
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

N469238130501 followed by a unit qualifier and the quantity

Package 69238-1305-01. 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 indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. 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 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-1305

What is NDC 69238-1305?
69238-1305 is the product NDC for Clobazam, Clobazam 10 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clobazam.
What is the active ingredient?
Clobazam.
Who is the labeler?
Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clobazam?
29 other product NDCs are listed under this name. See all Clobazam 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 Clobazam NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ClobazamClobazam 2.5 mg/mLSuspensionOralPrecision Dose, Inc.68094-07468094-0074-58
ClobazamClobazam 5 mg/1TabletOralAscend Laboratories, LLC67877-66467877-0664-0167877-0664-0567877-0664-33
ClobazamClobazam 10 mg/1TabletOralNovadoz Pharmaceuticals LLC72205-04772205-0047-91
ClobazamClobazam 20 mg/1TabletOralNovadoz Pharmaceuticals LLC72205-04872205-0048-91
ClobazamClobazam 2.5 mg/mLSuspensionOralAurobindo Pharma Limited59651-40159651-0401-12
ClobazamClobazam 2.5 mg/mLSuspensionOralBryant Ranch Prepack72162-260872162-2608-02
ClobazamClobazam 2.5 mg/mLSuspensionOralSun Pharmaceutical Industries, Inc.51672-422751672-4227-08
ClobazamClobazam 2.5 mg/mLSuspensionOralAscend Laboratories, LLC67877-65867877-0658-61
ClobazamClobazam 2.5 mg/mLSuspensionOralNorthStar RxLLC16714-08716714-0087-01
ClobazamClobazam 2.5 mg/mLSuspensionOralChartwell RX, LLC62135-52762135-0527-41

All 30 Clobazam NDCs

Other NDCs under ANDA 209718

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

FDA NDC Directory listings under ANDA 209718
ProductStrengthForm · routeLabelerProduct NDC
ClobazamClobazam 10 mg/1TabletOralAmerican Health Packaging60687-423
ClobazamClobazam 20 mg/1TabletOralAmneal Pharmaceuticals NY LLC69238-1306

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