FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
12634-531
11-digit product format
126340531
Labeler code
12634
Product ID
12634-531_2a2ec5f4-ddaa-383d-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA085762
Marketing category
ANDA
Marketing start
1977-11-17
Marketing end
0000-00-00
Substance
DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
Active strength
3 mg/1; mg/1
Pharmacologic classes
Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CV
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 conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12634-531-002021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-502021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-542021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-552021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-592021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-602021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-612021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-792021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-802021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-822021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-912021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-952021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
12634-531-972021-01-29C16284748780-1ba0f9c33-54e9-a910-e053-dadaa90a0b85620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-531-00Diphenoxylate Hydrochloride and Atropine Sulfate10 in 1 BOTTLETABLET1014
12634-531-50Diphenoxylate Hydrochloride and Atropine Sulfate50 in 1 BOTTLETABLET5014
12634-531-54Diphenoxylate Hydrochloride and Atropine Sulfate14 in 1 BLISTER PACKTABLET1414
12634-531-55Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BLISTER PACKTABLET1514
12634-531-59Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BLISTER PACKTABLET3014
12634-531-60Diphenoxylate Hydrochloride and Atropine Sulfate60 in 1 BOTTLETABLET6014
12634-531-61Diphenoxylate Hydrochloride and Atropine Sulfate10 in 1 BLISTER PACKTABLET1014
12634-531-79Diphenoxylate Hydrochloride and Atropine Sulfate25 in 1 BOTTLETABLET2514
12634-531-80Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLETABLET2014
12634-531-82Diphenoxylate Hydrochloride and Atropine Sulfate12 in 1 BOTTLETABLET1214
12634-531-91Diphenoxylate Hydrochloride and Atropine Sulfate1 in 1 BLISTER PACKTABLET114
12634-531-95Diphenoxylate Hydrochloride and Atropine Sulfate5 in 1 BOTTLETABLET514
12634-531-97Diphenoxylate Hydrochloride and Atropine Sulfate7 in 1 BOTTLETABLET714

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]1
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]1
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]1
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-531DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA INC.]14Legacy NDC, 13 package rows20160412_620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad14
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-531-001263405310010 in 1 BOTTLEHistorical
12634-531-501263405315050 in 1 BOTTLEHistorical
12634-531-541263405315414 in 1 BLISTER PACKHistorical
12634-531-551263405315515 in 1 BLISTER PACKHistorical
12634-531-591263405315930 in 1 BLISTER PACKHistorical
12634-531-601263405316060 in 1 BOTTLEHistorical
12634-531-611263405316110 in 1 BLISTER PACKHistorical
12634-531-791263405317925 in 1 BOTTLEHistorical
12634-531-801263405318020 in 1 BOTTLEHistorical
12634-531-821263405318212 in 1 BOTTLEHistorical
12634-531-91126340531911 in 1 BLISTER PACKHistorical
12634-531-95126340531955 in 1 BOTTLEHistorical
12634-531-97126340531977 in 1 BOTTLEHistorical