Prescription drug · ANDA
Chlordiazepoxide Hydrochloride NDC 68071-5256
Chlordiazepoxide hydrochloride 25 mg/1 · Capsule · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5256-6 | 68071525606 | 6 CAPSULE in 1 BOTTLE (68071-5256-6)Marketed from May 12, 2020 |
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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084769
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 68071-5256_1d78c293-2347-7b8b-e063-6394a90ae4e3SPL ID 1d78c293-2347-7b8b-e063-6394a90ae4e3SPL set ID a57a5046-f73b-10a9-e053-2a95a90ad72fRxCUI 905495UNII MFM6K1XWDKUPC 0368071525663
- 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
N468071525606followed by a unit qualifier and the quantityPackage 68071-5256-06. 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 084769
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 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0157 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | American Health Packaging | 60687-807 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-015 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0555-0159 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5171 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-046 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-020 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-1590 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | Couper LLC | 67046-0910 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-141 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0015 |