cetirizine hydrochloride

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

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

cetirizine hydrochloride 5 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-682
Product ID 49483-682_dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078933
Listing Expiration 2026-12-31
Marketing Start 2022-05-30

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 49483682
Hyphenated Format 49483-682

Supplemental Identifiers

RxCUI
1014676
UPC
0349483682014
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 (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078933 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (49483-682-01)
source: ndc

Packages (1)

49483-682-01 100 TABLET in 1 BOTTLE (49483-682-01)

Ingredients (1)

cetirizine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6", "openfda": {"upc": ["0349483682014"], "unii": ["64O047KTOA"], "rxcui": ["1014676"], "spl_set_id": ["dfbddafb-9455-5805-e053-2a95a90ad0d9"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (49483-682-01)", "package_ndc": "49483-682-01", "marketing_start_date": "20220530"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "49483-682_dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "49483-682", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078933", "marketing_category": "ANDA", "marketing_start_date": "20220530", "listing_expiration_date": "20261231"}