Prescription drug · NDA
Temazepam NDC 71610-004
Temazepam 7.5 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-004-30 | 71610000430 | 30 CAPSULE in 1 BOTTLE (71610-004-30)Marketed from Aug 14, 2017 | |
| 71610-004-53 | 71610000453 | 60 CAPSULE in 1 BOTTLE (71610-004-53)Marketed from Nov 22, 2017 | |
| 71610-004-60 | 71610000460 | 90 CAPSULE in 1 BOTTLE (71610-004-60)Marketed from Nov 22, 2017 |
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)
- Temazepam
- Generic name (nonproprietary)
- temazepam
- Active ingredients
- Temazepam — 7.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- 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 71610-004_a14e308f-61dd-47d4-bb0f-c69f9704c46bSPL ID a14e308f-61dd-47d4-bb0f-c69f9704c46bSPL set ID 405b1ee2-777b-4fd3-b4ee-bd2aacbe1dc1RxCUI 198243UNII 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
N471610000430followed by a unit qualifier and the quantityPackage 71610-0004-30. 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)
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 |
| 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 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 |