Prescription drug · ANDA
temazepam NDC 63187-132
Temazepam 15 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-132-30 | 63187013230 | 30 CAPSULE in 1 BOTTLE (63187-132-30)Marketed from Jan 1, 2019 | |
| 63187-132-60 | 63187013260 | 60 CAPSULE in 1 BOTTLE (63187-132-60)Marketed from Jun 8, 2023 | |
| 63187-132-90 | 63187013290 | 90 CAPSULE in 1 BOTTLE (63187-132-90)Marketed from Jun 8, 2023 |
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 — 15 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071456
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 63187-132_297f2ef3-a614-4992-b087-fe26108471f4SPL ID 297f2ef3-a614-4992-b087-fe26108471f4SPL set ID 904b8986-24da-48eb-bb0a-33d41b4eb005RxCUI 198241UNII CHB1QD2QSSUPC 0363187132309
- 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
N463187013230followed by a unit qualifier and the quantityPackage 63187-0132-30. 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 .
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 ANDA 071456
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 | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0191 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0647 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2900 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1824 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | Proficient Rx LP | 71205-914 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8603 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8602 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-312 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0295 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 55289-196 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1619 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-473 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8139 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | AvPAK | 50268-779 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-146 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0186 |