NDC codes

FDA NDC Directory
Product NDC (as listed)71335-9741Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-9741Add 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 NDC11-digit (billing)PackageCopy
71335-9741-17133597410120 CAPSULE in 1 BOTTLE (71335-9741-1)Marketed from Jul 10, 2023
71335-9741-27133597410230 CAPSULE in 1 BOTTLE (71335-9741-2)Marketed from Jul 10, 2023
71335-9741-37133597410360 CAPSULE in 1 BOTTLE (71335-9741-3)Marketed from Jul 10, 2023
71335-9741-47133597410490 CAPSULE in 1 BOTTLE (71335-9741-4)Marketed from Jul 10, 2023
71335-9741-57133597410528 CAPSULE in 1 BOTTLE (71335-9741-5)Marketed from Jul 10, 2023
71335-9741-671335974106120 CAPSULE in 1 BOTTLE (71335-9741-6)Marketed from Jul 10, 2023
71335-9741-771335974107100 CAPSULE in 1 BOTTLE (71335-9741-7)Marketed from Jul 10, 2023

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 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211542
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 71335-9741_5fb01933-af3d-4abe-b7d0-8f410a0a6d39SPL ID 5fb01933-af3d-4abe-b7d0-8f410a0a6d39SPL set ID 44461dcc-5c1e-4852-92d3-854ac0849e3dRxCUI 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

N471335974101 followed by a unit qualifier and the quantity

Package 71335-9741-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Temazepam capsules 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 71335-9741

What is NDC 71335-9741?
71335-9741 is the product NDC for Temazepam, Temazepam 15 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TemazepamTemazepam 15 mg/1CapsuleOralAmneal Pharmaceuticals of New York LLC53746-55653746-0556-0153746-0556-05
TemazepamTemazepam 30 mg/1CapsuleOralAmneal Pharmaceuticals of New York LLC53746-55753746-0557-0153746-0557-05
temazepamTemazepam 15 mg/1CapsuleOralAvPAK50268-77950268-0779-15
temazepamTemazepam 30 mg/1CapsuleOralAvPAK50268-78050268-0780-13
TemazepamTemazepam 15 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-849368788-8493-03
TemazepamTemazepam 30 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-029580425-0295-0180425-0295-0280425-0295-03
TemazepamTemazepam 30 mg/1CapsuleOralSolco Healthcare U.S., LLC43547-61443547-0614-1043547-0614-50
TemazepamTemazepam 7.5 mg/1CapsuleOralSolco Healthcare U.S., LLC43547-61143547-0611-10
TemazepamTemazepam 15 mg/1CapsuleOralSolco Healthcare U.S., LLC43547-61243547-0612-1043547-0612-50
TemazepamTemazepam 22.5 mg/1CapsuleOralSolco Healthcare U.S., LLC43547-61343547-0613-03

All 84 Temazepam NDCs

Other NDCs under ANDA 211542

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

FDA NDC Directory listings under ANDA 211542
ProductStrengthForm · routeLabelerProduct NDC
TemazepamTemazepam 22.5 mg/1CapsuleOralBryant Ranch Prepack71335-2043
TemazepamTemazepam 30 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-986
TemazepamTemazepam 15 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-507
TemazepamTemazepam 30 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-508
TemazepamTemazepam 15 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-8493
TemazepamTemazepam 30 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-382
TemazepamTemazepam 7.5 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-379
TemazepamTemazepam 15 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-380
TemazepamTemazepam 22.5 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-381
TemazepamTemazepam 7.5 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-379
TemazepamTemazepam 15 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-380
TemazepamTemazepam 22.5 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-381
TemazepamTemazepam 30 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-382

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