NDC codes

FDA NDC Directory
Product NDC (as listed)43063-518Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43063-0518Add 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
43063-518-0643063051806430630518066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-06)Marketed from Jul 24, 2012
43063-518-12430630518124306305181212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-12)Marketed from Jul 24, 2012
43063-518-20430630518204306305182020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-20)Marketed from Jul 24, 2012
43063-518-28430630518284306305182828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-28)Marketed from Jul 24, 2012
43063-518-30430630518304306305183030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-30)Marketed from Jul 24, 2012
43063-518-40430630518404306305184040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-40)Marketed from Jul 24, 2012
43063-518-60430630518604306305186060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-60)Marketed from Dec 18, 2019
43063-518-90430630518904306305189090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-518-90)Marketed from Jul 24, 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)
Hydroxyzine Hydrochloride
Generic name (nonproprietary)
hydroxyzine hydrochloride
Active ingredients
Hydroxyzine dihydrochloride — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040787
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 43063-518_4138e4f8-23cf-c563-e063-6294a90ad9bbSPL ID 4138e4f8-23cf-c563-e063-6294a90ad9bbSPL set ID 24cb9c83-a7e4-4bae-997c-c3a87426f78cRxCUI 995258UNII 76755771U3
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

N443063051806 followed by a unit qualifier and the quantity

Package 43063-0518-06. 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 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 a premedication and following general anesthesia, hydroxyzine may potentiate meperidine 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 43063-518

What is NDC 43063-518?
43063-518 is the product NDC for Hydroxyzine Hydrochloride, Hydroxyzine dihydrochloride 25 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 8 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydroxyzine Hydrochloride.
What is the active ingredient?
Hydroxyzine dihydrochloride.
Who is the labeler?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 Hydrochloride?
194 other product NDCs are listed under this name. See all Hydroxyzine Hydrochloride 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 Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 10 mg/5mLSolutionOralAdvagen Pharma Limited72888-21872888-0218-13
Hydroxyzine hydrochlorideHydroxyzine hydrochloride 50 mg/1TabletOralCoupler LLC67046-056667046-0566-03
Hydroxyzine hydrochlorideHydroxyzine hydrochloride 10 mg/1TabletOralCoupler LLC67046-083367046-0833-03
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-059080425-0590-0180425-0590-0280425-0590-03
Hydroxyzine hydrochlorideHydroxyzine hydrochloride 50 mg/1TabletOralUnit Dose Solutions, Inc.87441-03987441-0039-01
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 10 mg/5mLSolutionOralSaptalis Pharmaceuticals, LLC.71656-09071656-0090-16
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralCoupler LLC67046-131167046-1311-03
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 25 mg/1TabletOralCoupler LLC67046-071367046-0713-03
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 10 mg/5mLSolutionOralANI Pharmaceuticals, Inc.70954-91270954-0912-10
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-214855154-2148-00

All 195 Hydroxyzine Hydrochloride NDCs

Other NDCs under ANDA 040787

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

FDA NDC Directory listings under ANDA 040787
ProductStrengthForm · routeLabelerProduct NDC
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-962
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1730

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