Prescription drug · ANDA
Clorazepate Dipotassium NDC 13107-321
Clorazepate dipotassium 15 mg/1 · Tablet · Oral · Aurolife Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-321-01 | 13107032101 | 100 TABLET in 1 BOTTLE, PLASTIC (13107-321-01)Marketed from Jul 17, 1987 |
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 — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurolife Pharma LLCNDC labeler code 13107
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071858
- Marketing start
- Marketing end
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 13107-321_5da093d0-dc77-4240-97f1-d1e0ccc622ffSPL ID 5da093d0-dc77-4240-97f1-d1e0ccc622ffSPL set ID 919cbd07-f587-4005-acff-26213dd1d1fbRxCUI 197464, 197465, 197466UNII 63FN7G03XYUPC 0313107319013, 0313107320019, 0313107321016
- 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
N413107032101followed by a unit qualifier and the quantityPackage 13107-0321-01. 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 indicatedfor the management of anxiety disordersorfortheshort-term relief of the symptoms of anxiety. Anxiety or tensionassociatedwith the stress of everyday life usually does not require treatmentwith an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctivetherapy in themanagement of partialseizures. Theeffectiveness of Clorazepate dipotassium tablets in long-term management of anxiety, that is,more than 4 months, has not beenassessed by systematicclinicalstudies.Long-term studies in epilepticpatients,however, have showncontinuedtherapeuticactivity.Thephysician should reassessperiodically the usefulnessof the drug f…
Excerpt only. Read the full label for complete information.
About NDC 13107-321
- What is NDC 13107-321?
- 13107-321 is the product NDC for Clorazepate Dipotassium, Clorazepate dipotassium 15 mg/1 tablet, listed with the FDA by Aurolife Pharma 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?
- Aurolife Pharma LLC, NDC labeler code 13107. 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 | 67046-1462 | 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 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 |
Other NDCs under ANDA 071858
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 3.75 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-282 |
| Clorazepate Dipotassium | Clorazepate dipotassium 7.5 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-283 |
| Clorazepate Dipotassium | Clorazepate dipotassium 15 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-284 |
| Clorazepate Dipotassium | Clorazepate dipotassium 3.75 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-319 |
| Clorazepate Dipotassium | Clorazepate dipotassium 7.5 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-320 |