dye free childrens cetirizine hydrocholride

Generic: cetirizine hcl

Labeler: precision dose, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dye free childrens cetirizine hydrocholride
Generic Name cetirizine hcl
Labeler precision dose, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-004
Product ID 68094-004_16b6f804-4056-45a4-8764-8ca4256b3b43
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204226
Listing Expiration 2026-12-31
Marketing Start 2016-10-26

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 68094004
Hyphenated Format 68094-004

Supplemental Identifiers

RxCUI
1014673
UNII
64O047KTOA

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 dye free childrens cetirizine hydrocholride (source: ndc)
Generic Name cetirizine hcl (source: ndc)
Application Number ANDA204226 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 3 TRAY in 1 CASE (68094-004-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-004-59)
source: ndc

Packages (1)

68094-004-62 3 TRAY in 1 CASE (68094-004-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-004-59)

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Dye Free Childrens Cetirizine Hydrocholride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16b6f804-4056-45a4-8764-8ca4256b3b43", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["6a7c4dff-66c6-4d0c-af10-d908c65a43be"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (68094-004-62)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-004-59)", "package_ndc": "68094-004-62", "marketing_start_date": "20161026"}], "brand_name": "Dye Free Childrens Cetirizine Hydrocholride", "product_id": "68094-004_16b6f804-4056-45a4-8764-8ca4256b3b43", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68094-004", "generic_name": "cetirizine hcl", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dye Free Childrens Cetirizine Hydrocholride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA204226", "marketing_category": "ANDA", "marketing_start_date": "20161026", "listing_expiration_date": "20261231"}