NDC 43063-957

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 Pd-rx Pharmaceuticals, In. The primary component is Diphenoxylate H.

Product ID43063-957_840fbb33-dc74-3ebc-e053-2991aa0a3405
NDC43063-957
Product TypeHuman Prescription Drug
Proprietary NameDiphenoxylate hydrochloride and atropine sulfate
Generic NameDiphenoxylate Hydrochloride And Atropine Sulfate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA210571
Labeler NamePD-Rx Pharmaceuticals, In
Substance NameDIPHENOXYLATE H
Active Ingredient Strength3 mg/1; mg/1
Pharm ClassesAntidiarrheal [
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-957-04

4 TABLET in 1 BOTTLE, PLASTIC (43063-957-04)
Marketing Start Date2019-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-957-10 [43063095710]

Diphenoxylate hydrochloride and atropine sulfate TABLET
Marketing CategoryANDA
Application NumberANDA210571
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-02

NDC 43063-957-04 [43063095704]

Diphenoxylate hydrochloride and atropine sulfate TABLET
Marketing CategoryANDA
Application NumberANDA210571
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-02

NDC 43063-957-20 [43063095720]

Diphenoxylate hydrochloride and atropine sulfate TABLET
Marketing CategoryANDA
Application NumberANDA210571
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-13

NDC 43063-957-15 [43063095715]

Diphenoxylate hydrochloride and atropine sulfate TABLET
Marketing CategoryANDA
Application NumberANDA210571
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-29

Drug Details

Active Ingredients

IngredientStrength
DIPHENOXYLATE HYDROCHLORIDE2.5 mg/1

OpenFDA Data

SPL SET ID:11b9c1e8-34ee-4072-93eb-302e1e7e3e72
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1190572
    • UPC Code
  • 0343063957202

    • Pharmacological Class

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.