berkley jensen allergy relief

Generic: fexofenadine hydrochloride

Labeler: bjwc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name berkley jensen allergy relief
Generic Name fexofenadine hydrochloride
Labeler bjwc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fexofenadine hydrochloride 180 mg/1

Manufacturer
BJWC

Identifiers & Regulatory

Product NDC 68391-847
Product ID 68391-847_fa75f437-073a-439d-8282-d6a60fe2cbcf
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA212971
Listing Expiration 2027-12-31
Marketing Start 2022-02-27

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 68391847
Hyphenated Format 68391-847

Supplemental Identifiers

RxCUI
997420
UNII
2S068B75ZU

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 berkley jensen allergy relief (source: ndc)
Generic Name fexofenadine hydrochloride (source: ndc)
Application Number ANDA212971 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 180 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68391-847-47) / 150 TABLET, FILM COATED in 1 BOTTLE
  • 2 BOTTLE in 1 PACKAGE (68391-847-48) / 180 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

68391-847-47 1 BOTTLE in 1 CARTON (68391-847-47) / 150 TABLET, FILM COATED in 1 BOTTLE 68391-847-48 2 BOTTLE in 1 PACKAGE (68391-847-48) / 180 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

fexofenadine hydrochloride (180 mg/1)

Linked Drug Pages (1)

berkley jensen allergy relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fa75f437-073a-439d-8282-d6a60fe2cbcf", "openfda": {"unii": ["2S068B75ZU"], "rxcui": ["997420"], "spl_set_id": ["2c6d9f8c-bc74-4e1a-bd51-50f84ab63a15"], "manufacturer_name": ["BJWC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68391-847-47)  / 150 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "68391-847-47", "marketing_start_date": "20220227"}, {"sample": false, "description": "2 BOTTLE in 1 PACKAGE (68391-847-48)  / 180 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "68391-847-48", "marketing_start_date": "20250904"}], "brand_name": "berkley jensen allergy relief", "product_id": "68391-847_fa75f437-073a-439d-8282-d6a60fe2cbcf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68391-847", "generic_name": "fexofenadine hydrochloride", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "berkley jensen allergy relief", "active_ingredients": [{"name": "FEXOFENADINE HYDROCHLORIDE", "strength": "180 mg/1"}], "application_number": "ANDA212971", "marketing_category": "ANDA", "marketing_start_date": "20220227", "listing_expiration_date": "20271231"}