Temazepam NDC 65162-557

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-557Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0557Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
65162-557-03	65162055703	30 CAPSULE in 1 BOTTLE (65162-557-03)Marketed from May 23, 2016
65162-557-10	65162055710	100 CAPSULE in 1 BOTTLE (65162-557-10)Marketed from May 23, 2016
65162-557-11	65162055711	1000 CAPSULE in 1 BOTTLE (65162-557-11)Marketed from May 23, 2016
65162-557-50	65162055750	500 CAPSULE in 1 BOTTLE (65162-557-50)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 — 30 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203482
Marketing start: May 23, 2016
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 65162-557_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

N465162055703 followed by a unit qualifier and the quantity

Package 65162-0557-03. 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 Oct 30, 2024. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203482

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203482
Product	Strength	Form · route	Labeler	Product NDC
Temazepam	Temazepam 15 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-556
Temazepam	Temazepam 7.5 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-583
Temazepam	Temazepam 22.5 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-584
Temazepam	Temazepam 30 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1901
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