NDC codes

FDA NDC Directory
Product NDC (as listed)62135-750Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0750Add 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
62135-750-4762135075047473 mL in 1 BOTTLE (62135-750-47)Marketed from Aug 9, 2023

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/5mL
Dosage form
Syrup
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 087294
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 62135-750_25117412-3663-105d-e063-6394a90a0d64SPL ID 25117412-3663-105d-e063-6394a90a0d64SPL set ID 53b2d731-f38a-47c0-9e5c-abd3b45e2fe1RxCUI 995241UNII 76755771U3UPC 0362135750473
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

N462135075047 followed by a unit qualifier and the quantity

Package 62135-0750-47. 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 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 087294

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

FDA NDC Directory listings under ANDA 087294
ProductStrengthForm · routeLabelerProduct NDC
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/25mLSyrupOralChartwell Governmental & Specialty RX, LLC.68999-050
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/25mLSyrupOralChartwell RX, LLC62135-050
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 10 mg/5mLSyrupOralProficient Rx LP63187-494

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