NDC codes

FDA NDC Directory
Product NDC (as listed)14539-674Labeler and product segments. Claims need a package NDC.
Product NDC at billing width14539-0674Add 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
14539-674-011453906740114539067401100 CAPSULE in 1 CONTAINER (14539-674-01)Marketed from Apr 23, 2019
14539-674-051453906740514539067405500 CAPSULE in 1 CONTAINER (14539-674-05)Marketed from Apr 23, 2019

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)
hydroxyzine pamoate
Generic name (nonproprietary)
hydroxyzine pamoate
Active ingredients
Hydroxyzine pamoate — 25 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201507
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 14539-674_843627c2-146c-4715-b5b5-8c5c80a8f615SPL ID 843627c2-146c-4715-b5b5-8c5c80a8f615SPL set ID 734d32c8-38d3-430f-a2b3-539e03a3687aRxCUI 995253, 995278UNII M20215MUFR
Pharmacologic class
Antihistamine

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

N414539067401 followed by a unit qualifier and the quantity

Package 14539-0674-01. 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 .

Indications (excerpt from the label)

INDICATIONS For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 14539-674

What is NDC 14539-674?
14539-674 is the product NDC for hydroxyzine pamoate, Hydroxyzine pamoate 25 mg/1 capsule, listed with the FDA by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
hydroxyzine pamoate.
What is the active ingredient?
Hydroxyzine pamoate.
Who is the labeler?
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., NDC labeler code 14539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for hydroxyzine pamoate?
81 other product NDCs are listed under this name. See all hydroxyzine pamoate 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 hydroxyzine pamoate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-08787441-0087-01
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-04087441-0040-01
Hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-04187441-0041-01
Hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-04287441-0042-01
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralCoupler LLC67046-028167046-0281-03
Hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralCoupler LLC67046-083167046-0831-03
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralCoupler LLC67046-208667046-2086-03
hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralREMEDYREPACK INC.70518-446370518-4463-0070518-4463-01
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralBryant Ranch Prepack72162-105472162-1054-03
hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-878968788-8789-03

All 82 hydroxyzine pamoate NDCs

Other NDCs under ANDA 201507

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

FDA NDC Directory listings under ANDA 201507
ProductStrengthForm · routeLabelerProduct NDC
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralCoupler LLC67046-2086
hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-3583
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-001
hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-002
hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralPreferred Pharmaceuticals Inc.68788-8789
hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralBryant Ranch Prepack71335-1265
hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.14539-675
hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralREMEDYREPACK INC.70518-4463
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralBryant Ranch Prepack71335-1325
Hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralChartwell RX, LLC62135-817
Hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralChartwell RX, LLC62135-816
Hydroxyzine PamoateHydroxyzine pamoate 25 mg/1CapsuleOralDirect_Rx72189-009
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-773
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralMajor Pharmaceuticals0904-7065
hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralA-S Medication Solutions50090-7540
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralNorthwind Health Company, LLC51655-725
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralProficient Rx LP71205-433
hydroxyzine pamoateHydroxyzine pamoate 50 mg/1CapsuleOralNorthwind Health Company, LLC82868-046
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7767
hydroxyzine pamoateHydroxyzine pamoate 25 mg/1CapsuleOralA-S Medication Solutions50090-4385

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