What is NDC 72603-112?

72603-112 is the product NDC for Clorazepate Dipotassium, Clorazepate dipotassium 3.75 mg/1 tablet, listed with the FDA by NORTHSTAR RX LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

NORTHSTAR RX LLC, NDC labeler code 72603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clorazepate Dipotassium?

24 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clorazepate Dipotassium NDC 72603-112

NDC codes

FDA NDC Directory

Product NDC (as listed)72603-112Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72603-0112Add 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 NDC	11-digit (billing)	Package	Copy
72603-112-01	7260301120172603011201	100 TABLET in 1 BOTTLE (72603-112-01)Marketed from Oct 24, 2022
72603-112-02	7260301120272603011202	500 TABLET in 1 BOTTLE (72603-112-02)Marketed from Oct 24, 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): Clorazepate Dipotassium
Generic name (nonproprietary): clorazepate dipotassium
Active ingredients: Clorazepate dipotassium — 3.75 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NORTHSTAR RX LLCNDC labeler code 72603
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075731
Marketing start: Oct 24, 2022
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 72603-112_258be954-8e31-2be4-e063-6394a90a78caSPL ID 258be954-8e31-2be4-e063-6394a90a78caSPL set ID fb5c9e98-02b2-4c36-b436-25b58fe3c7d5RxCUI 197464, 197465, 197466UNII 63FN7G03XY
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

N472603011201 followed by a unit qualifier and the quantity

Package 72603-0112-01. 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 Oct 28, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clorazepate dipotassium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefuln…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72603-112

What is NDC 72603-112?: 72603-112 is the product NDC for Clorazepate Dipotassium, Clorazepate dipotassium 3.75 mg/1 tablet, listed with the FDA by NORTHSTAR RX LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clorazepate Dipotassium.
What is the active ingredient?: Clorazepate dipotassium.
Who is the labeler?: NORTHSTAR RX LLC, NDC labeler code 72603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clorazepate Dipotassium?: 24 other product NDCs are listed under this name. See all Clorazepate Dipotassium 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 Clorazepate Dipotassium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	Coupler LLC	67046-1601	67046-1601-03
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Coupler LLC	67046-1462	67046-1462-03
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Coupler LLC	67046-1501	67046-1501-03
Clorazepate Dipotassium	Clorazepate dipotassium 3.75 mg/1	TabletOral	Aurolife Pharma LLC	13107-282	13107-0282-0113107-0282-05
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	Aurolife Pharma LLC	13107-283	13107-0283-0113107-0283-05
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Aurolife Pharma LLC	13107-284	13107-0284-01
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-157	70954-0157-1070954-0157-2070954-0157-40
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	NORTHSTAR RX LLC	72603-113	72603-0113-0172603-0113-02
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	NORTHSTAR RX LLC	72603-114	72603-0114-01
Clorazepate Dipotassium	Clorazepate dipotassium 3.75 mg/mg	TabletOral	Apotex Corp.	60505-4754	60505-4754-01

All 25 Clorazepate Dipotassium NDCs

Other NDCs under ANDA 075731

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

FDA NDC Directory listings under ANDA 075731
Product	Strength	Form · route	Labeler	Product NDC
Clorazepate Dipotassium	Clorazepate dipotassium 3.75 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4042
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4043
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4044
Clorazepate Dipotassium	Clorazepate dipotassium 3.75 mg/1	TabletOral	Clinical Solutions Wholesale, LLC	58118-4042
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	Clinical Solutions Wholesale, LLC	58118-4043
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Clinical Solutions Wholesale, LLC	58118-4044
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	Coupler LLC	67046-1501
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	Coupler LLC	67046-1601
Clorazepate Dipotassium	Clorazepate dipotassium 7.5 mg/1	TabletOral	NORTHSTAR RX LLC	72603-113
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	NORTHSTAR RX LLC	72603-114
Clorazepate Dipotassium	Clorazepate dipotassium 15 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-256