Home NDC 63868-334 Allergy Relief
Product NDC 63868-334
11-digit product format 638680334
Labeler code 63868
Product ID 63868-334_24357d51-61dd-61b5-e063-6294a90a12c3
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION INC
Application ANDA211075
Marketing category ANDA
Marketing start 2021-07-06
Substance FEXOFENADINE HYDROCHLORIDE
Active strength 180 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Allergy Relief FEXOFENADINE HYDROCHLORIDE CHAIN DRUG MARKETING ASSOCIATION INC c5d58d74-da08-eb72-e053-2a95a90adc27 2024-10-11 Warnings Exact identifier
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 right away (1-800-222-1222).
Additional Listing Data#
Finished product Yes
Brand name base Allergy Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEXOFENADINE HYDROCHLORIDE 180 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 2S068B75ZU Rxcui 997420
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63868-334-15 Allergy Relief 5 in 1 BLISTER PACK TABLET 5 4 63868-334-15 Allergy Relief 3 in 1 CARTON TABLET 3 4 63868-334-30 Allergy Relief 1 in 1 CARTON TABLET 1 4 63868-334-30 Allergy Relief 30 in 1 BOTTLE, PLASTIC TABLET 30 4 63868-334-45 Allergy Relief 1 in 1 BOTTLE, PLASTIC TABLET 1 4 63868-334-45 Allergy Relief 45 in 1 BOTTLE, PLASTIC TABLET 45 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-334 ALLERGY RELIEF (FEXOFENADINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC] 4 Current NDC, Legacy NDC, 6 package rows 20241013_c5d58d74-da08-eb72-e053-2a95a90adc27.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 63868-334-15 63868033415 3 BLISTER PACK in 1 CARTON (63868-334-15) / 5 TABLET in 1 BLISTER PACK 3 blister pack 2021-07-06 2026-11-30 No No Current 63868-334-30 63868033430 1 BOTTLE, PLASTIC in 1 CARTON (63868-334-30) / 30 TABLET in 1 BOTTLE, PLASTIC 2021-07-06 2027-02-28 No No Current 63868-334-45 63868033445 1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (63868-334-45) / 45 TABLET in 1 BOTTLE, PLASTIC 2021-07-06 0000-00-00 No No Current