simply right childrens cetirizine

Generic: cetirizine hydrochloride

Labeler: sam's west inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name simply right childrens cetirizine
Generic Name cetirizine hydrochloride
Labeler sam's west inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer
Sam's West Inc

Identifiers & Regulatory

Product NDC 68196-102
Product ID 68196-102_1ba5f59e-81b7-c660-e063-6394a90af7fd
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090182
Listing Expiration 2026-12-31
Marketing Start 2011-09-08

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 68196102
Hyphenated Format 68196-102

Supplemental Identifiers

RxCUI
1014673
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 simply right childrens cetirizine (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA090182 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 2 BOTTLE in 1 CARTON (68196-102-02) / 120 mL in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (68196-102-07) / 240 mL in 1 BOTTLE
source: ndc

Packages (2)

68196-102-02 2 BOTTLE in 1 CARTON (68196-102-02) / 120 mL in 1 BOTTLE 68196-102-07 2 BOTTLE in 1 CARTON (68196-102-07) / 240 mL in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

SIMPLY RIGHT childrens cetirizine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1ba5f59e-81b7-c660-e063-6394a90af7fd", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["48b47541-cf0c-48a7-9a65-2158fd1284f1"], "manufacturer_name": ["Sam's West Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 CARTON (68196-102-02)  / 120 mL in 1 BOTTLE", "package_ndc": "68196-102-02", "marketing_start_date": "20110908"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (68196-102-07)  / 240 mL in 1 BOTTLE", "package_ndc": "68196-102-07", "marketing_start_date": "20110908"}], "brand_name": "SIMPLY RIGHT childrens cetirizine", "product_id": "68196-102_1ba5f59e-81b7-c660-e063-6394a90af7fd", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68196-102", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Sam's West Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SIMPLY RIGHT", "brand_name_suffix": "childrens cetirizine", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA090182", "marketing_category": "ANDA", "marketing_start_date": "20110908", "listing_expiration_date": "20261231"}