Home NDC 30142-059-84 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Product NDC 30142-059
Requested package NDC 30142-059-84
11-digit product format 301420059
Labeler code 30142
Product ID 30142-059_9902b6fe-db86-4b16-9302-c194c98aa97e
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler KROGER COMPANY
Application ANDA209116
Marketing category ANDA
Marketing start 2021-03-15
Substance FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 60; 120 mg/1; mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209116-001 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG TABLET, EXTENDED RELEASE / ORAL 2017-10-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 2 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-09-29 23:25 UTC 2022-09 A209116-001 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG TABLET, EXTENDED RELEASE / ORAL 2017-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209116-001 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG TABLET, EXTENDED RELEASE / ORAL 2017-10-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209116-001 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG TABLET, EXTENDED RELEASE / ORAL 2017-10-30 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEXOFENADINE HYDROCHLORIDE 60 mg/1 PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2S068B75ZU Internal UNII lookup 6V9V2RYJ8N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 997406 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 30142-059-20 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED, EXTENDED RE 10 4 30142-059-20 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 2 in 1 CARTON TABLET, FILM COATED, EXTENDED RE 2 4 30142-059-84 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 3 in 1 CARTON TABLET, FILM COATED, EXTENDED RE 3 4 30142-059-84 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED, EXTENDED RE 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 30142-059 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [KROGER COMPANY] 4 Current NDC, Legacy NDC, 4 package rows 20240613_b8b2c45d-3aba-d98a-e053-2a95a90a879b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 6 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 30142-059-84 30142005984 3 BLISTER PACK in 1 CARTON (30142-059-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 3 blister pack 2021-03-15 0000-00-00 No No Current