Prescription drug · ANDA

Hydroxyzine Hydrochloride NDC 72789-216

Hydroxyzine dihydrochloride 25 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)72789-216Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0216Add 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
72789-216-0472789021604727890216044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-04)Marketed from Aug 17, 2023
72789-216-12727890216127278902161212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-12)Marketed from Feb 14, 2022
72789-216-20727890216207278902162020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-20)Marketed from Mar 24, 2022
72789-216-30727890216307278902163030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-30)Marketed from Nov 30, 2021
72789-216-40727890216407278902164040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-40)Marketed from Nov 18, 2021
72789-216-60727890216607278902166060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-60)Marketed from Jun 24, 2022
72789-216-90727890216907278902169090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-216-90)Marketed from Dec 8, 2021

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 72789
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 088618
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 72789-216_3caab728-dec4-fe78-e063-6294a90a17ecSPL ID 3caab728-dec4-fe78-e063-6294a90a17ecSPL set ID 2b05bd0e-af57-4e74-92f8-a4311330142fRxCUI 995258UNII 76755771U3UPC 0372789216904
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

N472789021604 followed by a unit qualifier and the quantity

Package 72789-0216-04. 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 72789-216

What is NDC 72789-216?
72789-216 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 7 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 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 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 088618

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

FDA NDC Directory listings under ANDA 088618
ProductStrengthForm · routeLabelerProduct NDC
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralProficient Rx LP71205-155
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-8740
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 25 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-971
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2148
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2066
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-5061
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2279
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0935
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-589
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 25 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-675

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