What is NDC 63187-497?

63187-497 is the product NDC for temazepam, Temazepam 30 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. 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 63187-497 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-497Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0497Add 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
63187-497-00	6318704970063187049700	100 CAPSULE in 1 BOTTLE (63187-497-00)Marketed from Jan 1, 2019
63187-497-30	6318704973063187049730	30 CAPSULE in 1 BOTTLE (63187-497-30)Marketed from Jan 1, 2019
63187-497-60	6318704976063187049760	60 CAPSULE in 1 BOTTLE (63187-497-60)Marketed from Jan 1, 2019
63187-497-90	6318704979063187049790	90 CAPSULE in 1 BOTTLE (63187-497-90)Marketed from Jan 1, 2019

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: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 071457
Marketing start: Apr 21, 1987
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 63187-497_f2a9b002-a1ee-49e1-8477-0eb89fdbf1deSPL ID f2a9b002-a1ee-49e1-8477-0eb89fdbf1deSPL set ID 5aaf8c99-cd58-47fc-8bf5-1039a6315ca5RxCUI 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

N463187049700 followed by a unit qualifier and the quantity

Package 63187-0497-00. 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 Jan 1, 2021.

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 63187-497

What is NDC 63187-497?: 63187-497 is the product NDC for temazepam, Temazepam 30 mg/1 capsule, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 63187. 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 22.5 mg/1	CapsuleOral	Solco Healthcare U.S., LLC	43547-613	43547-0613-03
Temazepam	Temazepam 30 mg/1	CapsuleOral	Solco Healthcare U.S., LLC	43547-614	43547-0614-1043547-0614-50

All 84 temazepam NDCs

Other NDCs under ANDA 071457

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

FDA NDC Directory listings under ANDA 071457
Product	Strength	Form · route	Labeler	Product NDC
Temazepam	Temazepam 7.5 mg/1	CapsuleOral	Major Pharmaceuticals	0904-6436
temazepam	Temazepam 30 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	43353-260
temazepam	Temazepam 30 mg/1	CapsuleOral	A-S Medication Solutions	50090-0285
temazepam	Temazepam 30 mg/1	CapsuleOral	AvPAK	50268-780
temazepam	Temazepam 30 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	55289-660
temazepam	Temazepam 30 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-1057
temazepam	Temazepam 30 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-1621
temazepam	Temazepam 7.5 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8601
temazepam	Temazepam 22.5 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8604
temazepam	Temazepam 30 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8605
temazepam	Temazepam 30 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8606
temazepam	Temazepam 30 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	66267-321
temazepam	Temazepam 30 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-147
temazepam	Temazepam 7.5 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-148
temazepam	Temazepam 22.5 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-149
temazepam	Temazepam 30 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8081
temazepam	Temazepam 30 mg/1	CapsuleOral	Proficient Rx LP	71205-915
temazepam	Temazepam 30 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2302
temazepam	Temazepam 30 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2910
temazepam	Temazepam 30 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2965

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