NDC codes

FDA NDC Directory
Product NDC (as listed)60505-4756Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-4756Add 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
60505-4756-160505475601100 mg in 1 BOTTLE (60505-4756-1)Marketed from Sep 22, 2022

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)
Clorazepate Dipotassium
Generic name (nonproprietary)
clorazepate dipotassium
Active ingredients
Clorazepate dipotassium — 15 mg/mg
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215566
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 60505-4756_93fc1c54-8f73-3dcb-033f-4cd9411875ffSPL ID 93fc1c54-8f73-3dcb-033f-4cd9411875ffSPL set ID 6e07efe5-29b6-6d1e-661a-f696c4b17f43RxCUI 197464, 197465, 197466UNII 63FN7G03XYUPC 0360505475650, 0360505475612
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

N460505475601 followed by a unit qualifier and the quantity

Package 60505-4756-01. 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)

INDICATIONS AND USAGE Clorazepate dipotassium tablets are 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 th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215566

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

FDA NDC Directory listings under ANDA 215566
ProductStrengthForm · routeLabelerProduct NDC
Clorazepate DipotassiumClorazepate dipotassium 3.75 mg/mgTabletOralApotex Corp.60505-4754
Clorazepate DipotassiumClorazepate dipotassium 7.5 mg/mgTabletOralApotex Corp.60505-4755

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