Prescription drug · NDA AUTHORIZED GENERIC
Quazepam NDC 71993-265
Quazepam 15 mg/1 · Tablet · Oral · Atland Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71993-265-30 | 7199302653071993026530 | 30 TABLET in 1 BOTTLE (71993-265-30)Marketed from Mar 20, 2018 |
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)
- Quazepam
- Generic name (nonproprietary)
- quazepam
- Active ingredients
- Quazepam — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Atland Pharmaceuticals, LLCNDC labeler code 71993
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 018708
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 71993-265_41da82ab-fab6-7eba-e063-6394a90a037eSPL ID 41da82ab-fab6-7eba-e063-6394a90a037eSPL set ID f7d63f3f-5303-48ab-bce2-35fd62c45799RxCUI 198183UNII JF8V0828ZIUPC 0371993265302
- 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
N471993026530followed by a unit qualifier and the quantityPackage 71993-0265-30. 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)
Quazepam Tablets are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The effectiveness of Quazepam Tablets has been established in placebo-controlled clinical studies of 5 nights duration in acute and chronic insomnia. The sustained effectiveness of Quazepam Tablets has been established in chronic insomnia in a sleep lab (polysomnographic) study of 28 nights duration. Because insomnia is often transient and intermittent, the prolonged administration of Quazepam Tablets is generally not necessary or recommended. Since insomnia may be a symptom of several other disorders, the possibility that…
Excerpt only. Read the full label for complete information.
About NDC 71993-265
- What is NDC 71993-265?
- 71993-265 is the product NDC for Quazepam, Quazepam 15 mg/1 tablet, listed with the FDA by Atland Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Quazepam.
- What is the active ingredient?
- Quazepam.
- Who is the labeler?
- Atland Pharmaceuticals, LLC, NDC labeler code 71993. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Quazepam?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.