NDC codes

FDA NDC Directory
Product NDC (as listed)72789-449Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0449Add 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
72789-449-30727890449307278904493030 CAPSULE in 1 BOTTLE, PLASTIC (72789-449-30)Marketed from Nov 6, 2024

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 — 30 mg/1
Dosage form
Capsule
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 018163
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 72789-449_5d3329de-db3b-717d-e063-6394a90a3164SPL ID 5d3329de-db3b-717d-e063-6394a90a3164
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

N472789044930 followed by a unit qualifier and the quantity

Package 72789-0449-30. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 72789-449

What is NDC 72789-449?
72789-449 is the product NDC for Temazepam, Temazepam 30 mg/1 capsule, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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 30 mg/1CapsuleOralAmneal Pharmaceuticals of New York LLC53746-55753746-0557-0153746-0557-05
TemazepamTemazepam 15 mg/1CapsuleOralAmneal Pharmaceuticals of New York LLC53746-55653746-0556-0153746-0556-05
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 22.5 mg/1CapsuleOralSolco Healthcare U.S., LLC43547-61343547-0613-03
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

All 84 Temazepam NDCs

Other NDCs under NDA 018163

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

FDA NDC Directory listings under NDA 018163
ProductStrengthForm · routeLabelerProduct NDC
RestoriltemazepamTemazepam 22.5 mg/1CapsuleOralSpecGx LLC0406-9914
RestoriltemazepamTemazepam 7.5 mg/1CapsuleOralSpecGx LLC0406-9915
RestoriltemazepamTemazepam 15 mg/1CapsuleOralSpecGx LLC0406-9916
RestoriltemazepamTemazepam 30 mg/1CapsuleOralSpecGx LLC0406-9917
TemazepamTemazepam 22.5 mg/1CapsuleOralSpecGx LLC0406-9959
TemazepamTemazepam 7.5 mg/1CapsuleOralSpecGx LLC0406-9960
TemazepamTemazepam 15 mg/1CapsuleOralSpecGx LLC0406-9961
TemazepamTemazepam 30 mg/1CapsuleOralSpecGx LLC0406-9962
TemazepamTemazepam 7.5 mg/1CapsuleOralAmerican Health Packaging68084-549
TemazepamTemazepam 7.5 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-004
TemazepamTemazepam 15 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-625
TemazepamTemazepam 30 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-626

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