Prescription drug · ANDA
Chlordiazepoxide Hydrochloride NDC 58118-1033
Chlordiazepoxide hydrochloride 10 mg/1 · Capsule · Oral · Clinical Solutions Wholesale, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58118-1033-8 | 58118103308 | 30 CAPSULE in 1 BLISTER PACK (58118-1033-8)Marketed from Feb 19, 2019 |
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)
- Chlordiazepoxide Hydrochloride
- Generic name (nonproprietary)
- chlordiazepoxide hydrochloride
- Active ingredients
- Chlordiazepoxide hydrochloride — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 083116
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 58118-1033_0e85dcfa-d9dd-5fbb-e063-6394a90aeae6SPL ID 0e85dcfa-d9dd-5fbb-e063-6394a90aeae6SPL set ID 74c4320d-c90d-436b-97da-07496ba88aedRxCUI 905369UNII MFM6K1XWDK
- 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
N458118103308followed by a unit qualifier and the quantityPackage 58118-1033-08. 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 Chlordiazepoxide HCl capsules are indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of chlordiazepoxide HCl capsules in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 083116
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 |
|---|---|---|---|---|
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1752 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 10 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0555-0033 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 10 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-019 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-0909 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 10 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-375 |