What is NDC 72189-577?

72189-577 is the product NDC for Hydroxyzine HCL, Hydroxyzine dihydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_rx, NDC labeler code 72189. 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 HCL?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydroxyzine HCL NDC 72189-577 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-577Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0577Add 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 NDC	11-digit (billing)	Package	Copy
72189-577-60	7218905776072189057760	60 TABLET, FILM COATED in 1 BOTTLE (72189-577-60)Marketed from Sep 13, 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): Hydroxyzine HCL
Generic name (nonproprietary): hydroxyzine hcl
Active ingredients: Hydroxyzine dihydrochloride — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Direct_rxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217652
Marketing start: Sep 13, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 72189-577_22049012-733f-6b45-e063-6294a90a670fSPL ID 22049012-733f-6b45-e063-6294a90a670fSPL set ID 22049012-733e-6b45-e063-6294a90a670fRxCUI 995281UNII 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

N472189057760 followed by a unit qualifier and the quantity

Package 72189-0577-60. 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 Sep 13, 2024.

Indications (excerpt from the label)

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 in any way and it may be…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-577

What is NDC 72189-577?: 72189-577 is the product NDC for Hydroxyzine HCL, Hydroxyzine dihydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Direct_rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydroxyzine HCL.
What is the active ingredient?: Hydroxyzine dihydrochloride.
Who is the labeler?: Direct_rx, NDC labeler code 72189. 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 HCL?: 1 other product NDC are listed under this name. See all Hydroxyzine HCL 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 HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydroxyzine HCL	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0173	80425-0173-0180425-0173-02

Other NDCs under ANDA 217652

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

FDA NDC Directory listings under ANDA 217652
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 10 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-113
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-114
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	16571-115
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7327
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7329
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7330
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7331
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7332
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8112
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-8119
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 25 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-990
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1311
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 25 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc	68071-3964
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-5291
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-5296
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 25 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8707
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8872
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4141
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4170
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2410

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