Prescription drug · ANDA
Chlordiazepoxide Hydrochloride NDC 42806-565
Chlordiazepoxide hydrochloride 10 mg/1 · Capsule, Gelatin coated · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-565-01 | 42806056501 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-565-01)Marketed from Aug 13, 2021 |
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)
- Chlordiazepoxide Hydrochloride
- Generic name (nonproprietary)
- chlordiazepoxide hydrochloride
- Active ingredients
- Chlordiazepoxide hydrochloride — 10 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Epic Pharma, LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085472
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 42806-565_d7a3306e-01d4-4966-a473-62136d81f959SPL ID d7a3306e-01d4-4966-a473-62136d81f959SPL set ID 2e198c16-a929-4028-8f96-25dd23f74b10RxCUI 905369, 905495, 905516UNII MFM6K1XWDKUPC 0342806565018, 0342806566015, 0342806564011
- 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
N442806056501followed by a unit qualifier and the quantityPackage 42806-0565-01. 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 Chlordiazepoxide hydrochloride 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 hydrochloride 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.
About NDC 42806-565
- What is NDC 42806-565?
- 42806-565 is the product NDC for Chlordiazepoxide Hydrochloride, Chlordiazepoxide hydrochloride 10 mg/1 capsule, gelatin coated, listed with the FDA by Epic Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Chlordiazepoxide Hydrochloride.
- What is the active ingredient?
- Chlordiazepoxide hydrochloride.
- Who is the labeler?
- Epic Pharma, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Chlordiazepoxide Hydrochloride?
- 27 other product NDCs are listed under this name. See all Chlordiazepoxide Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Chlordiazepoxide Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-0909 | 67046-0909-03 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-015 | 87441-0015-01 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | Couper LLC | 67046-0910 | 67046-0910-03 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 10 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-019 | 48433-0019-20 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-020 | 48433-0020-20 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | American Health Packaging | 60687-807 | 60687-0807-01 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-141 | 51079-0141-20 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 10 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-375 | 51079-0375-20 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 5 mg/1 | Capsule, Gelatin coatedOral | Epic Pharma, LLC | 42806-564 | 42806-0564-01 |
| Chlordiazepoxide Hydrochloride | Chlordiazepoxide hydrochloride 25 mg/1 | Capsule, Gelatin coatedOral | Epic Pharma, LLC | 42806-566 | 42806-0566-01 |
Other NDCs under ANDA 085472
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 | Capsule, Gelatin coatedOral | Epic Pharma LLC | 42806-562 |