Prescription drug · ANDA

Hydroxyzine Hydrochloride NDC 24658-781

Hydroxyzine dihydrochloride 10 mg/1 · Tablet, Film coated · Oral · PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

NDC codes

FDA NDC Directory
Product NDC (as listed)24658-781Labeler and product segments. Claims need a package NDC.
Product NDC at billing width24658-0781Add 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
24658-781-0524658078105500 TABLET, FILM COATED in 1 BOTTLE (24658-781-05)Marketed from Oct 24, 2024
24658-781-10246580781101000 TABLET, FILM COATED in 1 BOTTLE (24658-781-10)Marketed from Jul 21, 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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040604
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 24658-781_384448bf-baa4-482b-91cd-585b03c62907SPL ID 384448bf-baa4-482b-91cd-585b03c62907SPL set ID 19fe26a9-eb1a-4c5b-a5e4-65223ee56ad1RxCUI 995218, 995258, 995281UNII 76755771U3UPC 0324658782102, 0324658781105, 0324658783109
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

N424658078105 followed by a unit qualifier and the quantity

Package 24658-0781-05. 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 in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040604

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

FDA NDC Directory listings under ANDA 040604
ProductStrengthForm · routeLabelerProduct NDC
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralEpic Pharma, LLC42806-161
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 10 mg/1Tablet, Film coatedOralEpic Pharma, LLC42806-159
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralEpic Pharma, LLC42806-160
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2167
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralProficient Rx LP71205-332
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5133
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2185
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-783
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-782
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 50 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6618

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Hydroxyzine Hydrochloride NDC 24658-781 | Med-Code