Prevacid SoluTab

Product NDC: 21695-106
11-digit product format: 216950106
Labeler code: 21695
Product ID: 21695-106_d15c8f36-4dcc-4b28-b03c-4e81b2f9ad2e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lansoprazole
Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021428
Marketing category: NDA
Marketing start: 2002-08-30
Marketing end: 0000-00-00
Substance: LANSOPRAZOLE
Active strength: 30 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d6b97638-59f4-48e2-8959-569628732c46	Product name	9	20210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-106-15	2019-09-24	C162847	48780-1	934fe258-4758-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for: PREVACID (lansoprazole) Delayed-Release Capsules PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets For oral administration Initial U.S. Approval: 1995

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-106-15	Prevacid SoluTab	15 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING, D	15		1

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-106-15	EA - Each	21695-106	7180367a-2792-4897-900f-d231328066af	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	PREVACID SOLUTAB (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	PREVACID SOLUTAB (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-106	PREVACID SOLUTAB (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110113_d15c8f36-4dcc-4b28-b03c-4e81b2f9ad2e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K5C5T2QPG	LANSOPRAZOLE	103577-45-3	LANSOPRAZOLE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-106-15	21695010615	15 in 1 BOTTLE	Historical