What is NDC 63629-8602?

63629-8602 is the product NDC for temazepam, Temazepam 15 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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 63629-8602 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8602Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8602Add 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
63629-8602-1	63629860201	100 CAPSULE in 1 BOTTLE (63629-8602-1)Marketed from Jul 13, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 071456
Marketing start: Apr 21, 1987
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 63629-8602_ad63b198-9c80-47d6-a755-dffdbd149c96SPL ID ad63b198-9c80-47d6-a755-dffdbd149c96SPL set ID 5dc0c671-3cd8-4e75-9e76-19c1c17b30b2RxCUI 198241UNII 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

N463629860201 followed by a unit qualifier and the quantity

Package 63629-8602-01. 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 Nov 3, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & 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 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 63629-8602

What is NDC 63629-8602?: 63629-8602 is the product NDC for temazepam, Temazepam 15 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. 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?: Bryant Ranch Prepack, NDC labeler code 63629. 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 071456

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

FDA NDC Directory listings under ANDA 071456
Product	Strength	Form · route	Labeler	Product NDC
temazepam	Temazepam 15 mg/1	CapsuleOral	AvPAK	50268-779
temazepam	Temazepam 15 mg/1	CapsuleOral	Ascend Laboratories, LLC	67877-146
temazepam	Temazepam 15 mg/1	CapsuleOral	A-S Medication Solutions	50090-0186
Temazepam	Temazepam 15 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0191
temazepam	Temazepam 15 mg/1	CapsuleOral	Proficient Rx LP	63187-132
temazepam	Temazepam 15 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-0647
Temazepam	Temazepam 30 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0295
temazepam	Temazepam 15 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2900
temazepam	Temazepam 15 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8139
temazepam	Temazepam 15 mg/1	CapsuleOral	Proficient Rx LP	71205-914
temazepam	Temazepam 15 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1824
temazepam	Temazepam 15 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-473
temazepam	Temazepam 15 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8603
temazepam	Temazepam 15 mg/1	CapsuleOral	Aphena Pharma Solutions - Tennessee, LLC	43353-312
temazepam	Temazepam 15 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	55289-196
temazepam	Temazepam 15 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-1619