NDC 43353-083

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 Aphena Pharma Solutions - Tennessee, Llc. The primary component is Diphenoxylate Hydrochloride; Atropine Sulfate.

• Product ID: 43353-083_a923a016-80b4-4a98-9494-ada455890843
• NDC: 43353-083
• Product Type: Human Prescription Drug
• Proprietary Name: Diphenoxylate Hydrochloride and Atropine Sulfate
• Generic Name: Diphenoxylate Hydrochloride And Atropine Sulfate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-02-27
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA012462
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
• Active Ingredient Strength: 3 mg/1; mg/1
• Pharm Classes: Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
• DEA Schedule: CV
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43353-083-30

30 TABLET in 1 BOTTLE (43353-083-30)

• Marketing Start Date: 2015-07-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43353-083-70 [43353008370]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA012462
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-13

NDC 43353-083-90 [43353008390]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA012462
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-27

NDC 43353-083-53 [43353008353]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA012462
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-14

NDC 43353-083-80 [43353008380]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA012462
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-08-15

NDC 43353-083-30 [43353008330]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA012462
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-13

NDC 43353-083-60 [43353008360]

Diphenoxylate Hydrochloride and Atropine Sulfate TABLET

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA012462
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-07-13

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENOXYLATE HYDROCHLORIDE	2.5 mg/1

OpenFDA Data

• SPL SET ID: 59934cee-4e1f-4958-9e97-6de53b39daf3
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • W24OD7YW48
  • 03J5ZE7KA5
• 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"

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