Lansoprazole

Product NDC: 70934-423
11-digit product format: 709340423
Labeler code: 70934
Product ID: 70934-423_90a5231a-23ac-2638-e053-2a95a90acc37
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lansoprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA091269
Marketing category: ANDA
Marketing start: 2019-08-01
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: No
Listing certified through: 2020-12-31
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
70934-423-30	2021-01-29	C162847	48780-1	ba0f9c33-144f-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use For oral administration Initial U.S. Approval: 1995

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70934-423-30	Lansoprazole	500 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	500		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-423	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20190822_90a529d4-9406-4b5a-e053-2995a90aff21.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	90a529d4-9406-4b5a-e053-2995a90aff21	1
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	90a529d4-9406-4b5a-e053-2995a90aff21	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
70934-423-30	70934042330	500 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2019-08-21	HUMAN PRESCRIPTION DRUG LABEL	1