APTIDINE

Product NDC
46084-031
11-digit product format
460840031
Labeler code
46084
Product ID
46084-031_cbc1050f-9b82-4e4c-aa84-78ba062e75b0
Type
HUMAN OTC DRUG
Nonproprietary name
RANITIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
A P J Laboratories Limited
Application
ANDA075132
Marketing category
ANDA
Marketing start
2013-03-01
Marketing end
0000-00-00
Substance
RANITIDINE HYDROCHLORIDE
Active strength
75 mg/1
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 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46084-031-11APTIDINE755 in 1 BLISTER PACKTABLET51
46084-031-12APTIDINE7512 in 1 BLISTER PACKTABLET121
46084-031-13APTIDINE7536 in 1 BLISTER PACKTABLET361
46084-031-14APTIDINE7560 in 1 BLISTER PACKTABLET601
46084-031-15APTIDINE75120 in 1 BLISTER PACKTABLET1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46084-031APTIDINE 75 (RANITIDINE HYDROCHLORIDE) TABLET [A P J LABORATORIES LIMITED]1Legacy NDC, 5 package rows20160609_549c0a03-bce9-4c0f-8f60-e6964f63dce2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312773ranitidine 75 MG Oral TabletPSN549c0a03-bce9-4c0f-8f60-e6964f63dce21
312773ranitidine 75 MG Oral TabletSCD549c0a03-bce9-4c0f-8f60-e6964f63dce21
312773ranitidine 75 MG (as ranitidine hydrochloride 84 MG) Oral TabletSY549c0a03-bce9-4c0f-8f60-e6964f63dce21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
46084-031-11460840031115 in 1 BLISTER PACKHistorical
46084-031-124608400311212 in 1 BLISTER PACKHistorical
46084-031-134608400311336 in 1 BLISTER PACKHistorical
46084-031-144608400311460 in 1 BLISTER PACKHistorical
46084-031-1546084003115120 in 1 BLISTER PACKHistorical