NDC codes

FDA NDC Directory
Product NDC (as listed)16714-087Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0087Add 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
16714-087-0116714008701167140087011 BOTTLE, GLASS in 1 CARTON (16714-087-01) / 120 mL in 1 BOTTLE, GLASSMarketed from May 1, 2020

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
NorthStar RxLLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209796
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 16714-087_f649cb16-8cb4-5292-e053-2995a90a04fcSPL ID f649cb16-8cb4-5292-e053-2995a90a04fcSPL set ID 574a3f91-d73e-46bc-b4a1-2388439521fbRxCUI 1366192UNII 2MRO291B4UUPC 0316714087016
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

N416714008701 followed by a unit qualifier and the quantity

Package 16714-0087-01. 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 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 oral suspension 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 16714-087

What is NDC 16714-087?
16714-087 is the product NDC for Clobazam, Clobazam 2.5 mg/mL suspension, listed with the FDA by NorthStar RxLLC. 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?
NorthStar RxLLC, NDC labeler code 16714. 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/mLSuspensionOralChartwell RX, LLC62135-52762135-0527-41
ClobazamClobazam 2.5 mg/mLSuspensionOralCamber Pharmaceuticals, Inc.31722-64131722-0641-12

All 30 Clobazam NDCs

Other NDCs under ANDA 209796

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

FDA NDC Directory listings under ANDA 209796
ProductStrengthForm · routeLabelerProduct NDC
ClobazamClobazam 2.5 mg/mLSuspensionOralCamber Pharmaceuticals, Inc.31722-641

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in