What is NDC 43547-613?

43547-613 is the product NDC for Temazepam, Temazepam 22.5 mg/1 capsule, listed with the FDA by Solco Healthcare U.S., LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Solco Healthcare U.S., LLC, NDC labeler code 43547. 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 43547-613 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-613Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0613Add 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
43547-613-03	43547061303	30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03)Marketed from Jan 5, 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 — 22.5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Solco Healthcare U.S., LLCNDC labeler code 43547
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201781
Marketing start: Jan 5, 2023
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 43547-613_5f04458d-b81c-47f8-ab06-3c47dffc5e4dSPL ID 5f04458d-b81c-47f8-ab06-3c47dffc5e4dSPL set ID 3ce42f0e-821e-4c9a-8f6b-60621628fd4bRxCUI 198241, 198242, 198243, 485489UNII CHB1QD2QSSUPC 0343547614102, 0343547611101, 0343547613037
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

N443547061303 followed by a unit qualifier and the quantity

Package 43547-0613-03. 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 Jul 25, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Temazepam is 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 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 43547-613

What is NDC 43547-613?: 43547-613 is the product NDC for Temazepam, Temazepam 22.5 mg/1 capsule, listed with the FDA by Solco Healthcare U.S., LLC. It has 1 package NDC, 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?: Solco Healthcare U.S., LLC, NDC labeler code 43547. 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 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 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 30 mg/1	CapsuleOral	Solco Healthcare U.S., LLC	43547-614	43547-0614-1043547-0614-50
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 201781

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

FDA NDC Directory listings under ANDA 201781
Product	Strength	Form · route	Labeler	Product NDC
Temazepam	Temazepam 7.5 mg/1	CapsuleOral	Solco Healthcare U.S., LLC	43547-611
Temazepam	Temazepam 15 mg/1	CapsuleOral	Solco Healthcare U.S., LLC	43547-612
Temazepam	Temazepam 30 mg/1	CapsuleOral	Solco Healthcare U.S., LLC	43547-614