Prescription drug · ANDA
Clorazepate Dipotassium NDC 72603-113
Clorazepate dipotassium 7.5 mg/1 · Tablet · Oral · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-113-01 | 72603011301 | 100 TABLET in 1 BOTTLE (72603-113-01)Marketed from Oct 24, 2022 | |
| 72603-113-02 | 72603011302 | 500 TABLET in 1 BOTTLE (72603-113-02)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 — 7.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NORTHSTAR RX LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075731
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 72603-113_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
N472603011301followed by a unit qualifier and the quantityPackage 72603-0113-01. 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 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.
Other NDCs under ANDA 075731
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clorazepate Dipotassium | Clorazepate dipotassium 15 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-256 |
| Clorazepate Dipotassium | Clorazepate dipotassium 15 mg/1 | TabletOral | Coupler LLC | 67046-1501 |
| Clorazepate Dipotassium | Clorazepate dipotassium 3.75 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-112 |
| Clorazepate Dipotassium | Clorazepate dipotassium 3.75 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4042 |
| Clorazepate Dipotassium | Clorazepate dipotassium 15 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-114 |
| 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 7.5 mg/1 | TabletOral | Coupler LLC | 67046-1601 |
| 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 |