FDA.reportPublic FDA data

Ranitidine

Product NDC
42291-725
11-digit product format
422910725
Labeler code
42291
Product ID
42291-725_a3419a0f-f911-521a-e053-2995a90a4ae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranitidine
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE, Inc.
Application
ANDA077824
Marketing category
ANDA
Marketing start
2014-08-18
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7f54af34-be54-4c3c-894f-78df6452d747Product name320190703
ccf8541e-b7dc-e6ba-06c9-15bf143a7850Product name520190611
05700d9e-ea6f-4aab-b0ed-1488f1d85d7bProduct name120180904
2f9d4e5c-e179-490e-8c43-f19e1e0ca228Product name120160720

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-725-01EA - Each42291-725219b687c-9f1e-451f-bf19-f0948f8f5cc412014-09-03
42291-725-25EA - Each42291-725374adef4-9ca6-46b9-b80a-42e061f7860012014-09-03
42291-725-30EA - Each42291-7253a51e7b5-7846-4b06-8c5e-1d6e5b3aca5512014-09-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198191ranitidine 150 MG Oral TabletPSN7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198193ranitidine 300 MG Oral TabletPSN7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198191ranitidine 150 MG Oral TabletSCD7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198193ranitidine 300 MG Oral TabletSCD7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198191ranitidine 150 MG (as ranitidine HCl 168 MG) Oral TabletSY7f3348a9-ce69-48d6-89f4-5c0e7d38a2552
198193ranitidine 300 MG (as ranitidine HCl 336 MG) Oral TabletSY7f3348a9-ce69-48d6-89f4-5c0e7d38a2552