Hydroxyzine hydrochloride

Product NDC: 55700-829
11-digit product format: 557000829
Labeler code: 55700
Product ID: 55700-829_762bfdc3-3a42-4475-9fab-c199d072e408
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Hydroxyzine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA204279
Marketing category: ANDA
Marketing start: 2019-12-13
Marketing end: 0000-00-00
Substance: HYDROXYZINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55700-829-30	2023-12-15	C162847	48780-1	f386c649-9996-0266-e053-dadaa90a7c1a	982b543c-dc0e-4de3-97f9-16efb3ff6a60
55700-829-30	2023-01-30	C162847	48780-1	f386c649-9996-0266-e053-dadaa90a7c1a	982b543c-dc0e-4de3-97f9-16efb3ff6a60

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-829-30	EA - Each	55700-829	abda6fd0-7c0c-4ffc-ae80-355bad078fdc	1	2020-01-03

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
76755771U3	HYDROXYZINE HYDROCHLORIDE	2192-20-3	HYDROXYZINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-829-30	55700082930	30 TABLET in 1 BOTTLE (55700-829-30)	30 tablet	2019-12-13	0000-00-00	No	No	Current