What is NDC 71610-625?

71610-625 is the product NDC for Temazepam, Temazepam 15 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 8 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-625 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-625Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0625Add 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
71610-625-10	71610062510	10 CAPSULE in 1 BOTTLE (71610-625-10)Marketed from Jun 14, 2024
71610-625-15	71610062515	15 CAPSULE in 1 BOTTLE (71610-625-15)Marketed from Dec 10, 2021
71610-625-20	71610062520	20 CAPSULE in 1 BOTTLE (71610-625-20)Marketed from Jun 14, 2024
71610-625-28	71610062528	28 CAPSULE in 1 BOTTLE (71610-625-28)Marketed from Jun 14, 2024
71610-625-30	71610062530	30 CAPSULE in 1 BOTTLE (71610-625-30)Marketed from Dec 10, 2021
71610-625-45	71610062545	45 CAPSULE in 1 BOTTLE (71610-625-45)Marketed from Dec 10, 2021
71610-625-53	71610062553	60 CAPSULE in 1 BOTTLE (71610-625-53)Marketed from Dec 10, 2021
71610-625-60	71610062560	90 CAPSULE in 1 BOTTLE (71610-625-60)Marketed from Dec 10, 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 — 15 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 018163
Marketing start: Feb 23, 2010
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 71610-625_1b2a670e-edfd-4ce9-e063-6294a90aaf23SPL ID 1b2a670e-edfd-4ce9-e063-6294a90aaf23SPL set ID a8deb28b-c5a3-4775-8bec-3f276698d064RxCUI 198241, 198242UNII CHB1QD2QSS
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

N471610062510 followed by a unit qualifier and the quantity

Package 71610-0625-10. 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 Jun 18, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND 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 USP 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 71610-625

What is NDC 71610-625?: 71610-625 is the product NDC for Temazepam, Temazepam 15 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 8 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 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

All 84 Temazepam NDCs

Other NDCs under NDA 018163

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

FDA NDC Directory listings under NDA 018163
Product	Strength	Form · route	Labeler	Product NDC
Temazepam	Temazepam 30 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-626
Restoriltemazepam	Temazepam 22.5 mg/1	CapsuleOral	SpecGx LLC	0406-9914
Restoriltemazepam	Temazepam 7.5 mg/1	CapsuleOral	SpecGx LLC	0406-9915
Temazepam	Temazepam 30 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-449
Restoriltemazepam	Temazepam 15 mg/1	CapsuleOral	SpecGx LLC	0406-9916
Restoriltemazepam	Temazepam 30 mg/1	CapsuleOral	SpecGx LLC	0406-9917
Temazepam	Temazepam 22.5 mg/1	CapsuleOral	SpecGx LLC	0406-9959
Temazepam	Temazepam 7.5 mg/1	CapsuleOral	SpecGx LLC	0406-9960
Temazepam	Temazepam 15 mg/1	CapsuleOral	SpecGx LLC	0406-9961
Temazepam	Temazepam 7.5 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	71610-004
Temazepam	Temazepam 30 mg/1	CapsuleOral	SpecGx LLC	0406-9962
Temazepam	Temazepam 7.5 mg/1	CapsuleOral	American Health Packaging	68084-549