NDC codes

FDA NDC Directory
Product NDC (as listed)67877-149Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0149Add 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
67877-149-0167877014901100 CAPSULE in 1 BOTTLE (67877-149-01)Marketed from Jun 28, 2012
67877-149-0567877014905500 CAPSULE in 1 BOTTLE (67877-149-05)Marketed from Jun 28, 2012
67877-149-306787701493030 CAPSULE in 1 BOTTLE (67877-149-30)Marketed from Jun 28, 2012

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 — 22.5 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Ascend Laboratories, LLCNDC labeler code 67877
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 071457
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 67877-149_23e08cbc-80d4-4938-8d56-10e7682b5336SPL ID 23e08cbc-80d4-4938-8d56-10e7682b5336SPL set ID 8f54731f-c5b7-492c-acb0-444c5fbb7029RxCUI 198241, 198242, 198243, 485489UNII CHB1QD2QSSUPC 0367877147017, 0367877146010, 0367877148014, 0367877149011
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

N467877014901 followed by a unit qualifier and the quantity

Package 67877-0149-01. 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 & 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 67877-149

What is NDC 67877-149?
67877-149 is the product NDC for temazepam, Temazepam 22.5 mg/1 capsule, listed with the FDA by Ascend Laboratories, LLC. It has 3 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?
Ascend Laboratories, LLC, NDC labeler code 67877. 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 30 mg/1CapsuleOralAvPAK50268-78050268-0780-13
temazepamTemazepam 15 mg/1CapsuleOralAvPAK50268-77950268-0779-15
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 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
TemazepamTemazepam 30 mg/1CapsuleOralSolco Healthcare U.S., LLC43547-61443547-0614-1043547-0614-50

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
ProductStrengthForm · routeLabelerProduct NDC
temazepamTemazepam 30 mg/1CapsuleOralA-S Medication Solutions50090-0285
temazepamTemazepam 30 mg/1CapsuleOralBryant Ranch Prepack71335-2302
temazepamTemazepam 30 mg/1CapsuleOralBryant Ranch Prepack63629-1057
temazepamTemazepam 30 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-8081
temazepamTemazepam 7.5 mg/1CapsuleOralAsclemed USA, Inc.76420-472
temazepamTemazepam 30 mg/1CapsuleOralAsclemed USA, Inc.76420-475
temazepamTemazepam 22.5 mg/1CapsuleOralAsclemed USA, Inc.76420-474
temazepamTemazepam 30 mg/1CapsuleOralProficient Rx LP71205-915
temazepamTemazepam 7.5 mg/1CapsuleOralBryant Ranch Prepack72162-1826
temazepamTemazepam 30 mg/1CapsuleOralBryant Ranch Prepack72162-1825
temazepamTemazepam 30 mg/1CapsuleOralBryant Ranch Prepack71335-2910
temazepamTemazepam 22.5 mg/1CapsuleOralBryant Ranch Prepack72162-1827
temazepamTemazepam 30 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC43353-260
temazepamTemazepam 7.5 mg/1CapsuleOralBryant Ranch Prepack63629-8601
temazepamTemazepam 30 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.66267-321
temazepamTemazepam 30 mg/1CapsuleOralBryant Ranch Prepack63629-8606
temazepamTemazepam 22.5 mg/1CapsuleOralBryant Ranch Prepack63629-8604
temazepamTemazepam 30 mg/1CapsuleOralBryant Ranch Prepack63629-8605
temazepamTemazepam 30 mg/1CapsuleOralBryant Ranch Prepack71335-2965
TemazepamTemazepam 7.5 mg/1CapsuleOralMajor Pharmaceuticals0904-6436

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