Home NDC 0363-8010 Allergy Relief
Product NDC 0363-8010
11-digit product format 003638010
Labeler code 0363
Product ID 0363-8010_904a3d35-5043-45e8-868c-3c8197e2743a
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler Walgreens
Application ANDA211075
Marketing category ANDA
Marketing start 2021-09-17
Marketing end 0000-00-00
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 2023-12-31
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.
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
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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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-8010 ALLERGY RELIEF (FEXOFENADINE HCL) TABLET, COATED [WALGREENS] 6 Legacy NDC 20250508_f87455f4-25a1-4882-82b0-e1b5554045a1.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-8010-05 00363801005 5 BLISTER PACK in 1 CARTON (0363-8010-05) > 1 TABLET, COATED in 1 BLISTER PACK 5 blister pack 2021-09-17 0000-00-00 No No Current 0363-8010-15 00363801015 15 BLISTER PACK in 1 CARTON (0363-8010-15) > 1 TABLET, COATED in 1 BLISTER PACK 15 blister pack 2021-09-17 0000-00-00 No No Current 0363-8010-30 00363801030 1 BOTTLE, PLASTIC in 1 BOX (0363-8010-30) > 30 TABLET, COATED in 1 BOTTLE, PLASTIC 2021-09-17 0000-00-00 No No Current 0363-8010-45 00363801045 1 BOTTLE, PLASTIC in 1 BOX (0363-8010-45) > 45 TABLET, COATED in 1 BOTTLE, PLASTIC 2021-09-17 0000-00-00 No No Current 0363-8010-70 00363801070 1 BOTTLE, PLASTIC in 1 BOX (0363-8010-70) > 70 TABLET, COATED in 1 BOTTLE, PLASTIC 2021-09-17 0000-00-00 No No Current 0363-8010-90 00363801090 1 BOTTLE, PLASTIC in 1 BOX (0363-8010-90) > 90 TABLET, COATED in 1 BOTTLE, PLASTIC 2021-09-17 0000-00-00 No No Current