NDC 12634-531

Diphenoxylate Hydrochloride and Atropine Sulfate

Diphenoxylate Hydrochloride And Atropine Sulfate

Diphenoxylate Hydrochloride and Atropine Sulfate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Apotheca Inc.. The primary component is Diphenoxylate Hydrochloride; Atropine Sulfate.

Product ID12634-531_2a2ec5f4-ddaa-383d-e054-00144ff8d46c
NDC12634-531
Product TypeHuman Prescription Drug
Proprietary NameDiphenoxylate Hydrochloride and Atropine Sulfate
Generic NameDiphenoxylate Hydrochloride And Atropine Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1977-11-17
Marketing CategoryANDA / ANDA
Application NumberANDA085762
Labeler NameApotheca Inc.
Substance NameDIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
Active Ingredient Strength3 mg/1; mg/1
Pharm ClassesAntidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 12634-531-54

14 TABLET in 1 BLISTER PACK (12634-531-54)
Marketing Start Date2013-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-531-91 [12634053191]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

NDC 12634-531-55 [12634053155]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

NDC 12634-531-54 [12634053154]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

NDC 12634-531-01 [12634053101]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1977-11-17
Marketing End Date2016-04-11

NDC 12634-531-71 [12634053171]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1977-11-17
Marketing End Date2016-04-11

NDC 12634-531-79 [12634053179]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-04

NDC 12634-531-82 [12634053182]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

NDC 12634-531-97 [12634053197]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

NDC 12634-531-00 [12634053100]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-10-04

NDC 12634-531-60 [12634053160]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

NDC 12634-531-85 [12634053185]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1977-11-17
Marketing End Date2016-04-11

NDC 12634-531-95 [12634053195]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

NDC 12634-531-61 [12634053161]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

NDC 12634-531-59 [12634053159]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

NDC 12634-531-80 [12634053180]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

NDC 12634-531-50 [12634053150]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET
Marketing CategoryANDA
Application NumberANDA085762
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-04

Drug Details

Active Ingredients

IngredientStrength
DIPHENOXYLATE HYDROCHLORIDE2.5 mg/1

OpenFDA Data

SPL SET ID:620bf3e4-46ef-4eaf-95b8-f3ffc1a937ad
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1190572

    • Pharmacological Class

    • Antidiarrheal [EPC]
    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]
    • Antidiarrheal [EPC]
    • Anticholinergic [EPC]
    • Cholinergic Antagonists [MoA]
    • Cholinergic Muscarinic Antagonist [EPC]
    • Cholinergic Muscarinic Antagonists [MoA]

    NDC Crossover Matching brand name "Diphenoxylate Hydrochloride and Atropine Sulfate" or generic name "Diphenoxylate Hydrochloride And Atropine Sulfate"

    NDCBrand NameGeneric Name
    0054-3194Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    0378-0415Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    0406-1236Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    0527-1170DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
    0615-7801Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    0832-0590Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfate
    12634-531Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    17856-1061Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    17856-3194Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    21695-688Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    33261-685Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    43063-089Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    43063-957Diphenoxylate hydrochloride and atropine sulfateDiphenoxylate hydrochloride and Atropine sulfate
    43353-083Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE
    43353-594Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    49884-771Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    50090-0039Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    50090-0040Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    50090-2641Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    50090-2872Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    50090-3452Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    50090-3456Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    50090-5589Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    50090-5592Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfate
    51293-618Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    68071-4063Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    68788-7021Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    68788-9135Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    70166-630Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    70518-0919Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    71335-0311Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    53002-3400Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    55289-102Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    55700-255Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    59762-1061Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    61919-080DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
    61919-405DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
    62559-490Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    63187-939Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    63187-254Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    66336-437Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    66267-082Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    66267-780Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    67296-1241Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    67296-1572Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    67296-0505Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    67544-021Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    76385-107Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
    67296-1675DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
    70518-2135Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine Sulfate
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