Childrens Allergy Relief

Product NDC: 63548-0662
11-digit product format: 635480662
Labeler code: 63548
Product ID: 63548-0662_ad1479f7-87d7-489b-aff5-e547de25edfe
Type: HUMAN OTC DRUG
Nonproprietary name: Fexofenadine HCL
Dosage form: TABLET
Route: ORAL
Labeler: PLD Acquisitions LLC DBA Av�ma Pharma Solutions
Application: ANDA204097
Marketing category: ANDA
Marketing start: 2019-10-01
Substance: FEXOFENADINE HYDROCHLORIDE
Active strength: 30 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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
FEXOFENADINE HYDROCHLORIDE	30 mg/1

Field, Values table
Field	Values
Unii	2S068B75ZU
Rxcui	997488

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63548-0662-5	2023-02-09	C162847	48780-1	f386c64a-3bb4-0266-e053-dadaa90a7c1a	DRUG FACTS
63548-0662-5	2023-01-30	C162847	48780-1	f386c64a-3bb4-0266-e053-dadaa90a7c1a	DRUG FACTS

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63548-0662-5	Childrens Allergy Relief	500 in 1 BOTTLE, PLASTIC	TABLET	500		6

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63548-0662	CHILDRENS ALLERGY RELIEF (FEXOFENADINE HCL) TABLET [PLD ACQUISITIONS LLC DBA AV&EACUTE;MA PHARMA SOLUTIONS]	6	Current NDC, Legacy NDC, 1 package rows	20230214_052d6191-1d9c-45c9-8c81-d19a977eded5.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S068B75ZU	FEXOFENADINE HYDROCHLORIDE	153439-40-8	FEXOFENADINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
997488	fexofenadine HCl 30 MG Oral Tablet	PSN	052d6191-1d9c-45c9-8c81-d19a977eded5	6
997488	fexofenadine hydrochloride 30 MG Oral Tablet	SCD	052d6191-1d9c-45c9-8c81-d19a977eded5	6

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63548-0662-5	63548066205	500 TABLET in 1 BOTTLE, PLASTIC (63548-0662-5)	500 tablet	2019-10-01	0000-00-00	No	No	Current