Prescription drug · ANDA
Clorazepate Dipotassium NDC 67046-1462
Clorazepate dipotassium 15 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1462-3 | 67046146203 | 30 TABLET in 1 BLISTER PACK (67046-1462-3)Marketed from Feb 4, 2025 |
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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213730
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 67046-1462_2d5938fe-3981-3cd5-e063-6394a90a99a9SPL ID 2d5938fe-3981-3cd5-e063-6394a90a99a9SPL set ID 2d592a27-f4cf-008a-e063-6394a90a2629RxCUI 197464UNII 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
N467046146203followed by a unit qualifier and the quantityPackage 67046-1462-03. 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 & 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 the …
Excerpt only. Read the full label for complete information.
About NDC 67046-1462
- What is NDC 67046-1462?
- 67046-1462 is the product NDC for Clorazepate Dipotassium, Clorazepate dipotassium 15 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?
- Coupler LLC, NDC labeler code 67046. 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.
Related NDCs: other Clorazepate Dipotassium products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 67046-1501 | 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 3.75 mg/1 | TabletOral | NORTHSTAR RX LLC | 72603-112 | 72603-0112-0172603-0112-02 |
| 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 |
Other NDCs under ANDA 213730
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 7.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-158 |
| Clorazepate Dipotassium | Clorazepate dipotassium 15 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-157 |
| Clorazepate Dipotassium | Clorazepate dipotassium 3.75 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-159 |