Prescription drug · ANDA

Hydroxyzine Hydrochloride NDC 67046-1311

Hydroxyzine dihydrochloride 25 mg/1 · Tablet, Film coated · Oral · Coupler LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67046-1311Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-1311Add 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
67046-1311-3670461311036704613110330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1311-3)Marketed from May 12, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Coupler LLCNDC labeler code 67046
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217652
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 67046-1311_519e5dbf-2f5a-c54a-e063-6294a90a7b54SPL ID 519e5dbf-2f5a-c54a-e063-6294a90a7b54SPL set ID 519e54e0-a613-e7b3-e063-6294a90a4452RxCUI 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

N467046131103 followed by a unit qualifier and the quantity

Package 67046-1311-03. 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 67046-1311

What is NDC 67046-1311?
67046-1311 is the product NDC for Hydroxyzine Hydrochloride, Hydroxyzine dihydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, 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?
Coupler LLC, NDC labeler code 67046. 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/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
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-87560687-0875-01

All 195 Hydroxyzine Hydrochloride NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Hydroxyzine HCLHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralDirect_rx72189-577
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 10 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-113
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-114
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.16571-115
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7327
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7329
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7330
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7331
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7332
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8112
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-8119
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 25 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-990
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc68071-3964
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-5291
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-5296
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 25 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8707
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8872
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4141
Hydroxyzine HydrochlorideHydroxyzine hydrochloride 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4170
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2410

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