loratadine 10 mg

Generic: loratadine tablets usp, 10 mg

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

Drug Facts

Product Profile

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

loratadine 10 mg/1

Manufacturer
TIME CAP LABORATORIES, INC.

Identifiers & Regulatory

Product NDC 49483-732
Product ID 49483-732_2c80ea14-8491-4d26-e063-6294a90aecf0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA219223
Listing Expiration 2026-12-31
Marketing Start 2025-01-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49483732
Hyphenated Format 49483-732

Supplemental Identifiers

RxCUI
311372
UPC
0349483732658
UNII
7AJO3BO7QN

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 loratadine 10 mg (source: ndc)
Generic Name loratadine tablets usp, 10 mg (source: ndc)
Application Number ANDA219223 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 365 TABLET in 1 BOTTLE (49483-732-65)
source: ndc

Packages (1)

49483-732-65 365 TABLET in 1 BOTTLE (49483-732-65)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

Loratadine 10 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c80ea14-8491-4d26-e063-6294a90aecf0", "openfda": {"upc": ["0349483732658"], "unii": ["7AJO3BO7QN"], "rxcui": ["311372"], "spl_set_id": ["2c80ea14-8490-4d26-e063-6294a90aecf0"], "manufacturer_name": ["TIME CAP LABORATORIES, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "365 TABLET in 1 BOTTLE (49483-732-65)", "package_ndc": "49483-732-65", "marketing_start_date": "20250125"}], "brand_name": "Loratadine 10 mg", "product_id": "49483-732_2c80ea14-8491-4d26-e063-6294a90aecf0", "dosage_form": "TABLET", "product_ndc": "49483-732", "generic_name": "Loratadine Tablets USP, 10 mg", "labeler_name": "TIME CAP LABORATORIES, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Loratadine 10 mg", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA219223", "marketing_category": "ANDA", "marketing_start_date": "20250125", "listing_expiration_date": "20261231"}