loratadine

Generic: loratadine

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

Drug Facts

Product Profile

Brand Name loratadine
Generic Name loratadine
Labeler time cap laboratories inc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

loratadine 10 mg/1

Manufacturer
TIME CAP LABORATORIES INC

Identifiers & Regulatory

Product NDC 49483-686
Product ID 49483-686_6c562c37-86ca-42c2-e053-2a91aa0a8a8a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206214
Listing Expiration 2026-12-31
Marketing Start 2016-10-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49483686
Hyphenated Format 49483-686

Supplemental Identifiers

RxCUI
828269
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 (source: ndc)
Generic Name loratadine (source: ndc)
Application Number ANDA206214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-07)
  • 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-30)
source: ndc

Packages (2)

49483-686-07 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-07) 49483-686-30 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-30)

Ingredients (1)

loratadine (10 mg/1)

Linked Drug Pages (1)

LORATADINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6c562c37-86ca-42c2-e053-2a91aa0a8a8a", "openfda": {"unii": ["7AJO3BO7QN"], "rxcui": ["828269"], "spl_set_id": ["85b26cf3-448c-4d4f-93a2-aa89530ec1f1"], "manufacturer_name": ["TIME CAP LABORATORIES INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-07)", "package_ndc": "49483-686-07", "marketing_start_date": "20161013"}, {"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-30)", "package_ndc": "49483-686-30", "marketing_start_date": "20161013"}], "brand_name": "LORATADINE", "product_id": "49483-686_6c562c37-86ca-42c2-e053-2a91aa0a8a8a", "dosage_form": "CAPSULE, LIQUID FILLED", "product_ndc": "49483-686", "generic_name": "LORATADINE", "labeler_name": "TIME CAP LABORATORIES INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "LORATADINE", "active_ingredients": [{"name": "LORATADINE", "strength": "10 mg/1"}], "application_number": "ANDA206214", "marketing_category": "ANDA", "marketing_start_date": "20161013", "listing_expiration_date": "20261231"}