Prescription drug · NDA
Restoril (Temazepam) NDC 0406-9915
Temazepam 7.5 mg/1 · Capsule · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-9915-01 | 00406991501 | 100 CAPSULE in 1 BOTTLE (0406-9915-01)Marketed from Feb 27, 1981 | |
| 0406-9915-03 | 00406991503 | 30 CAPSULE in 1 BOTTLE (0406-9915-03)Marketed from Feb 27, 1981 |
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)
- Restoril
- Generic name (nonproprietary)
- temazepam
- Active ingredients
- Temazepam — 7.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- SpecGx LLCNDC labeler code 0406
- 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 0406-9915_f0ee4fa9-cdff-4111-83a5-0885c81de4e4SPL ID f0ee4fa9-cdff-4111-83a5-0885c81de4e4SPL set ID bc56f7fd-1aaf-48ff-8aa7-d467e59e1015RxCUI 198241, 198242, 198243, 208463, 208464, 208465, 485489, 539384UNII 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
N400406991501followed by a unit qualifier and the quantityPackage 00406-9915-01. 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 Restoril ® (temazepam) is 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 Restoril ® (temazepam) 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.
About NDC 0406-9915
- What is NDC 0406-9915?
- 0406-9915 is the product NDC for Restoril (temazepam), Temazepam 7.5 mg/1 capsule, listed with the FDA by SpecGx LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Restoril (Temazepam).
- What is the active ingredient?
- Temazepam.
- Who is the labeler?
- SpecGx LLC, NDC labeler code 0406. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Restoril?
- 3 other product NDCs are listed under this name. See all Restoril NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Restoril products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Restoriltemazepam | Temazepam 22.5 mg/1 | CapsuleOral | SpecGx LLC | 0406-9914 | 00406-9914-03 |
| Restoriltemazepam | Temazepam 15 mg/1 | CapsuleOral | SpecGx LLC | 0406-9916 | 00406-9916-01 |
| Restoriltemazepam | Temazepam 30 mg/1 | CapsuleOral | SpecGx LLC | 0406-9917 | 00406-9917-01 |
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 22.5 mg/1 | CapsuleOral | SpecGx LLC | 0406-9914 |
| Restoriltemazepam | Temazepam 15 mg/1 | CapsuleOral | SpecGx LLC | 0406-9916 |
| Restoriltemazepam | Temazepam 30 mg/1 | CapsuleOral | SpecGx LLC | 0406-9917 |
| Temazepam | Temazepam 22.5 mg/1 | CapsuleOral | SpecGx LLC | 0406-9959 |
| 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 7.5 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-004 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-625 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-626 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-449 |