Prescription drug · ANDA
Temazepam NDC 65162-583
Temazepam 7.5 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-583-03 | 65162058303 | 30 CAPSULE in 1 BOTTLE (65162-583-03)Marketed from May 23, 2016 | |
| 65162-583-10 | 65162058310 | 100 CAPSULE in 1 BOTTLE (65162-583-10)Marketed from May 23, 2016 | |
| 65162-583-11 | 65162058311 | 1000 CAPSULE in 1 BOTTLE (65162-583-11)Marketed from May 23, 2016 | |
| 65162-583-50 | 65162058350 | 500 CAPSULE in 1 BOTTLE (65162-583-50)Marketed from May 23, 2016 |
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
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203482
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 65162-583_20d2675f-af6d-480c-9152-6f722fb1ea22SPL ID 20d2675f-af6d-480c-9152-6f722fb1ea22SPL set ID be68c6e0-17ad-40fe-9bc1-58abe24b53f6RxCUI 198241, 198242, 198243, 485489UNII CHB1QD2QSSUPC 0365162556032, 0365162584035, 0365162557039, 0365162583038, 0365168523106
- 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
N465162058303followed by a unit qualifier and the quantityPackage 65162-0583-03. 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.
About NDC 65162-583
- What is NDC 65162-583?
- 65162-583 is the product NDC for Temazepam, Temazepam 7.5 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 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?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 203482
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 | Amneal Pharmaceuticals of New York LLC | 53746-556 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-557 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-556 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-557 |
| Temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Amneal Pharmaceuticals LLC | 65162-584 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1901 |