Prescription drug · ANDA
Clorazepate Dipotassium NDC 13107-283
Clorazepate dipotassium 7.5 mg/1 · Tablet · Oral · Aurolife Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-283-01 | 13107028301 | 100 TABLET in 1 BOTTLE, PLASTIC (13107-283-01)Marketed from Sep 23, 2023 | |
| 13107-283-05 | 13107028305 | 500 TABLET in 1 BOTTLE, PLASTIC (13107-283-05)Marketed from Sep 23, 2023 |
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
- Aurolife Pharma LLCNDC labeler code 13107
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071858
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 13107-283_69451c35-dd9a-4690-8d5e-4dcfa8837620SPL ID 69451c35-dd9a-4690-8d5e-4dcfa8837620SPL set ID 69451c35-dd9a-4690-8d5e-4dcfa8837620RxCUI 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
N413107028301followed by a unit qualifier and the quantityPackage 13107-0283-01. 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.
About NDC 13107-283
- What is NDC 13107-283?
- 13107-283 is the product NDC for Clorazepate Dipotassium, Clorazepate dipotassium 7.5 mg/1 tablet, listed with the FDA by Aurolife Pharma 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?
- 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 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 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 15 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-321 |
| 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 |