Prescription drug · ANDA
Flurazepam Hydrochloride NDC 62135-736
Flurazepam hydrochloride 15 mg/1 · Capsule · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-736-30 | 62135073630 | 30 CAPSULE in 1 BOTTLE (62135-736-30)Marketed from Dec 19, 2023 | |
| 62135-736-90 | 62135073690 | 90 CAPSULE in 1 BOTTLE (62135-736-90)Marketed from Sep 8, 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)
- Flurazepam Hydrochloride
- Generic name (nonproprietary)
- flurazepam hydrochloride
- Active ingredients
- Flurazepam hydrochloride — 15 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072368
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 62135-736_25893c92-c8f1-567a-e063-6294a90a00d4SPL ID 25893c92-c8f1-567a-e063-6294a90a00d4SPL set ID 8f476891-1346-4e8c-ac1b-f8cbdc64f5a1RxCUI 1298088, 1298091UNII 756RDM536MUPC 0362135736309, 0362135736903, 0362135737306, 0362135737900
- 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
N462135073630followed by a unit qualifier and the quantityPackage 62135-0736-30. 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)
Flurazepam hydrochloride capsules are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings [see Clinical Studies ( 14 ) ]. Since insomnia is often transient and intermittent, short-term use is usually sufficient. Prolonged use of hypnotics is usually not indicated and should only be undertaken concomitantly with appropriate evaluation of the patient. Flurazepam, a gamma-aminobutyric (GABA A ) agonist, is indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. ( 1 )
Excerpt only. Read the full label for complete information.