NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8139Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8139Add 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
68788-8139-3687888139036878881390330 CAPSULE in 1 BOTTLE (68788-8139-3)Marketed from Feb 11, 2022

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
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 071456
Marketing start
Listing expires
DEA schedule
CIV
Other FDA classes
Benzodiazepines (Chemical structure)
Identifiers
Product ID 68788-8139_630551e1-0ac9-4130-b9eb-0e469cb458acSPL ID 630551e1-0ac9-4130-b9eb-0e469cb458ac
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

N468788813903 followed by a unit qualifier and the quantity

Package 68788-8139-03. 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 68788-8139

What is NDC 68788-8139?
68788-8139 is the product NDC for temazepam, Temazepam 15 mg/1 capsule, listed with the FDA by Preferred 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 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
ProductStrengthForm · routeLabelerProduct NDC
temazepamTemazepam 15 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC43353-312
temazepamTemazepam 15 mg/1CapsuleOralA-S Medication Solutions50090-0186
temazepamTemazepam 15 mg/1CapsuleOralAvPAK50268-779
temazepamTemazepam 15 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.55289-196
temazepamTemazepam 15 mg/1CapsuleOralProficient Rx LP63187-132
temazepamTemazepam 15 mg/1CapsuleOralBryant Ranch Prepack63629-1619
temazepamTemazepam 15 mg/1CapsuleOralBryant Ranch Prepack63629-8602
temazepamTemazepam 15 mg/1CapsuleOralBryant Ranch Prepack63629-8603
temazepamTemazepam 15 mg/1CapsuleOralAscend Laboratories, LLC67877-146
temazepamTemazepam 15 mg/1CapsuleOralREMEDYREPACK INC.70518-0647
temazepamTemazepam 15 mg/1CapsuleOralProficient Rx LP71205-914
temazepamTemazepam 15 mg/1CapsuleOralBryant Ranch Prepack71335-2900
temazepamTemazepam 15 mg/1CapsuleOralBryant Ranch Prepack72162-1824
temazepamTemazepam 15 mg/1CapsuleOralAsclemed USA, Inc.76420-473
TemazepamTemazepam 15 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0191
TemazepamTemazepam 30 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0295

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