Prescription drug · ANDA
Temazepam NDC 0228-2076
Temazepam 15 mg/1 · Capsule · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0228-2076-10 | 00228207610 | 100 CAPSULE in 1 BOTTLE (0228-2076-10)Marketed from Sep 30, 1990 | |
| 0228-2076-50 | 00228207650 | 500 CAPSULE in 1 BOTTLE (0228-2076-50)Marketed from Sep 30, 1990 |
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 — 15 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071620
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0228-2076_3050ee1e-c494-48ce-be40-6424e9661d87SPL ID 3050ee1e-c494-48ce-be40-6424e9661d87SPL set ID a4370eb4-b00d-4247-af8d-980e59fbbec6RxCUI 198241, 198242UNII CHB1QD2QSSUPC 0302282076101
- 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
N400228207610followed by a unit qualifier and the quantityPackage 00228-2076-10. 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 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 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 ANDA 071620
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 |
|---|---|---|---|---|
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0315 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Actavis Pharma, Inc. | 0228-2077 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2487 |
| Temazepamtemazepam civ | Temazepam 30 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4083 |