Prescription drug · ANDA
temazepam NDC 71205-915
Temazepam 30 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-915-00 | 71205091500 | 100 CAPSULE in 1 BOTTLE (71205-915-00)Marketed from Jul 14, 2021 | |
| 71205-915-30 | 71205091530 | 30 CAPSULE in 1 BOTTLE (71205-915-30)Marketed from Jul 14, 2021 | |
| 71205-915-55 | 71205091555 | 500 CAPSULE in 1 BOTTLE (71205-915-55)Marketed from Jul 14, 2021 | |
| 71205-915-60 | 71205091560 | 60 CAPSULE in 1 BOTTLE (71205-915-60)Marketed from Jul 14, 2021 | |
| 71205-915-72 | 71205091572 | 120 CAPSULE in 1 BOTTLE (71205-915-72)Marketed from Jul 14, 2021 | |
| 71205-915-90 | 71205091590 | 90 CAPSULE in 1 BOTTLE (71205-915-90)Marketed from Jul 14, 2021 |
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 — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071457
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 71205-915_40b473bd-d806-4631-a7ff-58ccc51fd201SPL ID 40b473bd-d806-4631-a7ff-58ccc51fd201SPL set ID ccf04879-3ad5-4fc3-89f5-879c97887017RxCUI 198241, 198242UNII CHB1QD2QSSUPC 0371205915308, 0371205914301
- 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
N471205091500followed by a unit qualifier and the quantityPackage 71205-0915-00. 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 & 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 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 71205-915
- What is NDC 71205-915?
- 71205-915 is the product NDC for temazepam, Temazepam 30 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- temazepam.
- What is the active ingredient?
- Temazepam.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for temazepam?
- 83 other product NDCs are listed under this name. See all temazepam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other temazepam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-556 | 53746-0556-0153746-0556-05 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-557 | 53746-0557-0153746-0557-05 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | AvPAK | 50268-779 | 50268-0779-15 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | AvPAK | 50268-780 | 50268-0780-13 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8493 | 68788-8493-03 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0295 | 80425-0295-0180425-0295-0280425-0295-03 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Solco Healthcare U.S., LLC | 43547-614 | 43547-0614-1043547-0614-50 |
| Temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Solco Healthcare U.S., LLC | 43547-611 | 43547-0611-10 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Solco Healthcare U.S., LLC | 43547-612 | 43547-0612-1043547-0612-50 |
| Temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Solco Healthcare U.S., LLC | 43547-613 | 43547-0613-03 |
Other NDCs under ANDA 071457
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 7.5 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6436 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-260 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0285 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | AvPAK | 50268-780 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 55289-660 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Proficient Rx LP | 63187-497 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1057 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1621 |
| temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8601 |
| temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8604 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8605 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8606 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 66267-321 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-147 |
| temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-148 |
| temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-149 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8081 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2302 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2910 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2965 |
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