Prescription drug · NDA
Temazepam NDC 0406-9959
Temazepam 22.5 mg/1 · Capsule · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-9959-03 | 00406995903 | 30 CAPSULE in 1 BOTTLE (0406-9959-03)Marketed from Feb 23, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Temazepam
- Generic name (nonproprietary)
- temazepam
- Active ingredients
- Temazepam — 22.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- SpecGx LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018163
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0406-9959_973fc0b9-31b8-4958-9cb6-bd1ae12538e9SPL ID 973fc0b9-31b8-4958-9cb6-bd1ae12538e9SPL set ID c9bc61b4-a579-4003-98da-b6f6e381c150RxCUI 198241, 198242, 198243, 485489UNII CHB1QD2QSS
- 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
N400406995903followed by a unit qualifier and the quantityPackage 00406-9959-03. 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 Temazepam Capsules USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018163
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 |
|---|---|---|---|---|
| Restoriltemazepam | Temazepam 15 mg/1 | CapsuleOral | SpecGx LLC | 0406-9916 |
| Temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-004 |
| Restoriltemazepam | Temazepam 30 mg/1 | CapsuleOral | SpecGx LLC | 0406-9917 |
| Temazepam | Temazepam 7.5 mg/1 | CapsuleOral | SpecGx LLC | 0406-9960 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | SpecGx LLC | 0406-9961 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | SpecGx LLC | 0406-9962 |
| Temazepam | Temazepam 7.5 mg/1 | CapsuleOral | American Health Packaging | 68084-549 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-626 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-625 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-449 |
| Restoriltemazepam | Temazepam 22.5 mg/1 | CapsuleOral | SpecGx LLC | 0406-9914 |
| Restoriltemazepam | Temazepam 7.5 mg/1 | CapsuleOral | SpecGx LLC | 0406-9915 |