cetirizine hydrochloride (allergy)

Generic: cetirizine hydrochloride

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (allergy)
Generic Name cetirizine hydrochloride
Labeler aurohealth llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-806
Product ID 58602-806_a74bd49f-8718-4483-9019-b761138669c9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209107
Listing Expiration 2027-12-31
Marketing Start 2018-07-20

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602806
Hyphenated Format 58602-806

Supplemental Identifiers

RxCUI
1014675
UPC
0358602806040
UNII
64O047KTOA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cetirizine hydrochloride (allergy) (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA209107 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-806-04) / 12 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-806-12) / 40 CAPSULE in 1 BOTTLE
  • 65 BOTTLE in 1 CARTON (58602-806-16) / 65 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-806-53) / 25 CAPSULE in 1 BOTTLE
source: ndc

Packages (4)

58602-806-04 1 BOTTLE in 1 CARTON (58602-806-04) / 12 CAPSULE in 1 BOTTLE 58602-806-12 1 BOTTLE in 1 CARTON (58602-806-12) / 40 CAPSULE in 1 BOTTLE 58602-806-16 65 BOTTLE in 1 CARTON (58602-806-16) / 65 CAPSULE in 1 BOTTLE 58602-806-53 1 BOTTLE in 1 CARTON (58602-806-53) / 25 CAPSULE in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride (Allergy) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a74bd49f-8718-4483-9019-b761138669c9", "openfda": {"upc": ["0358602806040"], "unii": ["64O047KTOA"], "rxcui": ["1014675"], "spl_set_id": ["ffbca2a4-8df0-4c85-adf9-9414cd706fb2"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-806-04)  / 12 CAPSULE in 1 BOTTLE", "package_ndc": "58602-806-04", "marketing_start_date": "20180720"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-806-12)  / 40 CAPSULE in 1 BOTTLE", "package_ndc": "58602-806-12", "marketing_start_date": "20180720"}, {"sample": false, "description": "65 BOTTLE in 1 CARTON (58602-806-16)  / 65 CAPSULE in 1 BOTTLE", "package_ndc": "58602-806-16", "marketing_start_date": "20180720"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-806-53)  / 25 CAPSULE in 1 BOTTLE", "package_ndc": "58602-806-53", "marketing_start_date": "20180720"}], "brand_name": "Cetirizine Hydrochloride (Allergy)", "product_id": "58602-806_a74bd49f-8718-4483-9019-b761138669c9", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "58602-806", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride (Allergy)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209107", "marketing_category": "ANDA", "marketing_start_date": "20180720", "listing_expiration_date": "20271231"}