What is NDC 71205-083?

71205-083 is the product NDC for Hydroxyzine Hydrochloride, Hydroxyzine dihydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydroxyzine Hydrochloride NDC 71205-083

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-083Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0083Add 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
71205-083-15	7120500831571205008315	15 TABLET, FILM COATED in 1 BOTTLE (71205-083-15)Marketed from Aug 1, 2018
71205-083-20	7120500832071205008320	20 TABLET, FILM COATED in 1 BOTTLE (71205-083-20)Marketed from Aug 1, 2018
71205-083-30	7120500833071205008330	30 TABLET, FILM COATED in 1 BOTTLE (71205-083-30)Marketed from Aug 1, 2018
71205-083-60	7120500836071205008360	60 TABLET, FILM COATED in 1 BOTTLE (71205-083-60)Marketed from Aug 1, 2018
71205-083-90	7120500839071205008390	90 TABLET, FILM COATED in 1 BOTTLE (71205-083-90)Marketed from Aug 1, 2018

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 — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 088619
Marketing start: Oct 22, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Histamine Receptor Antagonists (Mechanism)
Identifiers: Product ID 71205-083_6eebea17-bc98-49a2-854c-35267194f4c4SPL ID 6eebea17-bc98-49a2-854c-35267194f4c4SPL set ID 642ff329-c551-44f0-b340-49313db868c5RxCUI 995281UNII 76755771U3UPC 0371205083151
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

N471205008315 followed by a unit qualifier and the quantity

Package 71205-0083-15. 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 Nov 1, 2022.

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 71205-083

What is NDC 71205-083?: 71205-083 is the product NDC for Hydroxyzine Hydrochloride, Hydroxyzine dihydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 5 package NDCs, 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?: Proficient Rx LP, NDC labeler code 71205. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 10 mg/5mL	SolutionOral	Advagen Pharma Limited	72888-218	72888-0218-13
Hydroxyzine hydrochloride	Hydroxyzine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-0566	67046-0566-03
Hydroxyzine hydrochloride	Hydroxyzine hydrochloride 10 mg/1	TabletOral	Coupler LLC	67046-0833	67046-0833-03
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0590	80425-0590-0180425-0590-0280425-0590-03
Hydroxyzine hydrochloride	Hydroxyzine hydrochloride 50 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-039	87441-0039-01
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 10 mg/5mL	SolutionOral	Saptalis Pharmaceuticals, LLC.	71656-090	71656-0090-16
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1311	67046-1311-03
Hydroxyzine hydrochloride	Hydroxyzine dihydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-0713	67046-0713-03
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 10 mg/5mL	SolutionOral	ANI Pharmaceuticals, Inc.	70954-912	70954-0912-10
Hydroxyzine Hydrochloride	Hydroxyzine hydrochloride 25 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2148	55154-2148-00

All 195 Hydroxyzine Hydrochloride NDCs

Other NDCs under ANDA 088619

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

FDA NDC Directory listings under ANDA 088619
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyzine HCL	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0173
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals USA, Inc.	0093-5062
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-467
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0246
Hydroxyzine Hydrochloride	Hydroxyzine dihydrochloride 50 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-269