Prescription drug · ANDA

Hydroxyzine hydrochloride NDC 70518-2807

Hydroxyzine dihydrochloride 10 mg/1 · Tablet · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-2807Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-2807Add 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
70518-2807-0705182807007051828070030 TABLET in 1 BLISTER PACK (70518-2807-0)Marketed from Jul 8, 2020

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 — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204279
Marketing start
Listing expires
Other FDA classes
Histamine Receptor Antagonists (Mechanism)
Identifiers
Product ID 70518-2807_4aa35fdf-9b24-64c4-e063-6294a90a7e60SPL ID 4aa35fdf-9b24-64c4-e063-6294a90a7e60SPL set ID 71eea118-395c-4559-aed5-900b635674b8RxCUI 995218UNII 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

N470518280700 followed by a unit qualifier and the quantity

Package 70518-2807-00. 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)

About NDC 70518-2807

What is NDC 70518-2807?
70518-2807 is the product NDC for Hydroxyzine hydrochloride, Hydroxyzine dihydrochloride 10 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. 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?
REMEDYREPACK INC., NDC labeler code 70518. 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 204279

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

FDA NDC Directory listings under ANDA 204279
ProductStrengthForm · routeLabelerProduct NDC
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 25 mg/1TabletOralGolden State Medical Supply, Inc.51407-970
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 50 mg/1TabletOralGolden State Medical Supply, Inc.51407-971
Hydroxyzine hydrochlorideHydroxyzine hydrochloride 25 mg/1TabletOralMajor Pharmaceuticals0904-7378
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 50 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8564
Hydroxyzine hydrochlorideHydroxyzine hydrochloride 50 mg/1TabletOralUnit Dose Solutions, Inc.87441-039
Hydroxyzine hydrochlorideHydroxyzine hydrochloride 50 mg/1TabletOralMajor Pharmaceuticals0904-7379
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 10 mg/1TabletOralProficient Rx LP71205-541
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 50 mg/1TabletOralREMEDYREPACK INC.70518-0487
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 10 mg/1TabletOralGolden State Medical Supply, Inc.51407-969
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 10 mg/1TabletOralDirect Rx72189-333
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-0268
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 10 mg/1TabletOralNorthwind Health Company, LLC51655-076
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 25 mg/1TabletOralBryant Ranch Prepack71335-2340
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 25 mg/1TabletOralNorthwind Health Company, LLC51655-080
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 25 mg/1TabletOralProficient Rx LP63187-733
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-3583
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-4929
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 50 mg/1TabletOralNorthwind Health Company, LLC51655-119
Hydroxyzine hydrochlorideHydroxyzine dihydrochloride 50 mg/1TabletOralProficient Rx LP63187-354
Hydroxyzine HydrochlorideHydroxyzine dihydrochloride 10 mg/1TabletOralChartwell RX, LLC62135-573

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