cetirizine hydrochloride tablets,10 mg

Generic: cetirizine hydrochloride

Labeler: time cap laboratories, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride tablets,10 mg
Generic Name cetirizine hydrochloride
Labeler time cap laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-692
Product ID 49483-692_12f9d89b-5334-1339-e063-6394a90ad0e8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078933
Listing Expiration 2026-12-31
Marketing Start 2022-02-12

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 49483692
Hyphenated Format 49483-692

Supplemental Identifiers

RxCUI
1014678
UPC
0349483692501 0349483692655 0349483692013
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 tablets,10 mg (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078933 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (49483-692-01)
  • 200 TABLET in 1 BOTTLE (49483-692-20)
  • 500 TABLET in 1 BOTTLE (49483-692-50)
  • 365 TABLET in 1 BOTTLE (49483-692-65)
source: ndc

Packages (4)

49483-692-01 100 TABLET in 1 BOTTLE (49483-692-01) 49483-692-20 200 TABLET in 1 BOTTLE (49483-692-20) 49483-692-50 500 TABLET in 1 BOTTLE (49483-692-50) 49483-692-65 365 TABLET in 1 BOTTLE (49483-692-65)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride Tablets,10 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12f9d89b-5334-1339-e063-6394a90ad0e8", "openfda": {"upc": ["0349483692501", "0349483692655", "0349483692013"], "unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["d78223ba-80d5-47f8-e053-2a95a90aebdb"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (49483-692-01)", "package_ndc": "49483-692-01", "marketing_start_date": "20240311"}, {"sample": false, "description": "200 TABLET in 1 BOTTLE (49483-692-20)", "package_ndc": "49483-692-20", "marketing_start_date": "20240311"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (49483-692-50)", "package_ndc": "49483-692-50", "marketing_start_date": "20220530"}, {"sample": false, "description": "365 TABLET in 1 BOTTLE (49483-692-65)", "package_ndc": "49483-692-65", "marketing_start_date": "20220212"}], "brand_name": "Cetirizine Hydrochloride Tablets,10 mg", "product_id": "49483-692_12f9d89b-5334-1339-e063-6394a90ad0e8", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "49483-692", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride Tablets,10 mg", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078933", "marketing_category": "ANDA", "marketing_start_date": "20220212", "listing_expiration_date": "20261231"}