NDC codes

FDA NDC Directory
Product NDC (as listed)62135-527Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0527Add 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
62135-527-416213505274162135052741120 mL in 1 BOTTLE (62135-527-41)Marketed from Aug 1, 2022

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 — 2.5 mg/mL
Dosage form
Suspension
Route
Oral
Labeler
Chartwell RX, LLCNDC labeler code 62135
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213110
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 62135-527_181bd7dd-a848-7bc7-e063-6294a90a482cSPL ID 181bd7dd-a848-7bc7-e063-6294a90a482cSPL set ID 17c3b9db-9e25-4a17-ac45-bcd17ea0360cRxCUI 1366192UNII 2MRO291B4UUPC 0362135527419
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

N462135052741 followed by a unit qualifier and the quantity

Package 62135-0527-41. 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 Oral Suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam is 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 62135-527

What is NDC 62135-527?
62135-527 is the product NDC for Clobazam, Clobazam 2.5 mg/mL suspension, listed with the FDA by Chartwell RX, 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?
Chartwell RX, LLC, NDC labeler code 62135. 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/mLSuspensionOralCamber Pharmaceuticals, Inc.31722-64131722-0641-12

All 30 Clobazam NDCs

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