Ranitidine

Product NDC
35356-809
11-digit product format
353560809
Labeler code
35356
Product ID
35356-809_59f7cb2e-8d42-4bbf-8f6d-ee7b79a42b87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA077824
Marketing category
ANDA
Marketing start
2009-12-16
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-809-30EA - Each35356-809e8ae7e79-6ed6-4b02-b0ce-c5e1bd67184712013-02-13
35356-809-60EA - Each35356-8098c6e9315-f280-4ce6-8321-31483bef264a12016-02-04