NDC codes

FDA NDC Directory
Product NDC (as listed)67544-136Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67544-0136Add 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
67544-136-106754401361010 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-10)Marketed from Aug 26, 2004
67544-136-146754401361414 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-14)Marketed from Aug 26, 2004
67544-136-156754401361515 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-15)Marketed from Sep 16, 2004
67544-136-206754401362020 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-20)Marketed from Sep 1, 2004
67544-136-286754401362828 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-28)Marketed from Aug 30, 2009
67544-136-306754401363030 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-30)Marketed from Oct 16, 2004
67544-136-456754401364545 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-45)Marketed from Sep 1, 2004
67544-136-536754401365360 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-53)Marketed from Oct 16, 2004
67544-136-606754401366090 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-60)Marketed from Dec 8, 2004

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 67544
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 071638
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 67544-136_6d75ac66-4a65-487b-a938-7414907c2632SPL ID 6d75ac66-4a65-487b-a938-7414907c2632SPL set ID 2461dfbd-5704-42f4-bde7-d1461811d898RxCUI 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

N467544013610 followed by a unit qualifier and the quantity

Package 67544-0136-10. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Temazepam is indicated for the short-term treatment of insomnia (generally 7 - 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 - 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 67544-136

What is NDC 67544-136?
67544-136 is the product NDC for Temazepam, Temazepam 15 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 9 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 67544. 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

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