Home NDC 70692-134 Fexofenadine hydrochloride
Product NDC 70692-134
11-digit product format 706920134
Labeler code 70692
Product ID 70692-134_b43fc254-c365-5e80-e053-2a95a90a799f
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Strive Pharmaceuticals Inc
Application ANDA211075
Marketing category ANDA
Marketing start 2019-07-22
Marketing end 0000-00-00
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 180 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 70692-134 I Inactivated by FDA 2026-07-31 excluded package package 70692-134 70692-134-29 I Inactivated by FDA 2026-07-31
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211075-001 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2019-10-18 A211075-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2019-10-18
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70692-134-29 Fexofenadine hydrochloride 3 in 1 BLISTER PACK TABLET 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70692-134 FEXOFENADINE HYDROCHLORIDE TABLET [STRIVE PHARMACEUTICALS INC] 2 Legacy NDC, 1 package rows 20201117_9717c35e-cfd3-6605-e053-2995a90a1de5.zip
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 70692-134-29 70692013429 3 TABLET in 1 BLISTER PACK (70692-134-29) 3 tablet 2019-07-22 0000-00-00 No No Current