What is NDC 43353-312?

43353-312 is the product NDC for temazepam, Temazepam 15 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 43353-312 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-312Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0312Add 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
43353-312-10	43353031210	10 CAPSULE in 1 BOTTLE (43353-312-10)Marketed from Jun 27, 2018
43353-312-15	43353031215	15 CAPSULE in 1 BOTTLE (43353-312-15)Marketed from Sep 21, 2017
43353-312-28	43353031228	28 CAPSULE in 1 BOTTLE (43353-312-28)Marketed from Jun 27, 2018
43353-312-30	43353031230	30 CAPSULE in 1 BOTTLE (43353-312-30)Marketed from May 1, 2017
43353-312-45	43353031245	45 CAPSULE in 1 BOTTLE (43353-312-45)Marketed from Sep 21, 2017
43353-312-53	43353031253	60 CAPSULE in 1 BOTTLE (43353-312-53)Marketed from May 1, 2017
43353-312-60	43353031260	90 CAPSULE in 1 BOTTLE (43353-312-60)Marketed from May 1, 2017

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 43353
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 43353-312_ec1b0a54-5f93-45ed-bbbf-0bf3cd42ba73SPL ID ec1b0a54-5f93-45ed-bbbf-0bf3cd42ba73SPL set ID b2422ca0-2f06-419f-aa0e-88c556b62399RxCUI 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

N443353031210 followed by a unit qualifier and the quantity

Package 43353-0312-10. 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 Jan 23, 2024. 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 43353-312

What is NDC 43353-312?: 43353-312 is the product NDC for temazepam, Temazepam 15 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 7 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 43353. 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	63629-8602
temazepam	Temazepam 15 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-8603
temazepam	Temazepam 15 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	55289-196
temazepam	Temazepam 15 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-1619