What is NDC 53746-557?

53746-557 is the product NDC for Temazepam, Temazepam 30 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Temazepam NDC 53746-557 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-557Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0557Add 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	Copy
53746-557-01	53746055701	100 CAPSULE in 1 BOTTLE (53746-557-01)Marketed from Feb 19, 2024
53746-557-05	53746055705	500 CAPSULE in 1 BOTTLE (53746-557-05)Marketed from Feb 19, 2024

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 of New York LLCNDC labeler code 53746
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203482
Marketing start: Feb 19, 2024
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 53746-557_18d70b19-ff94-443e-8169-cb7e87895146SPL ID 18d70b19-ff94-443e-8169-cb7e87895146SPL set ID 6248295e-8176-48f8-8e9d-bba6deacaf0dRxCUI 198241, 198242UNII CHB1QD2QSSUPC 0353746557018, 0353746556011
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

N453746055701 followed by a unit qualifier and the quantity

Package 53746-0557-01. 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 Feb 16, 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)

About NDC 53746-557

What is NDC 53746-557?: 53746-557 is the product NDC for Temazepam, Temazepam 30 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 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 of New York LLC, NDC labeler code 53746. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Temazepam NDCs
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 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
Temazepam	Temazepam 15 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0191	80425-0191-0180425-0191-02

All 84 Temazepam NDCs

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 of New York LLC	53746-556
Temazepam	Temazepam 15 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-556
Temazepam	Temazepam 30 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-557
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