Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
0378-0415
11-digit product format
003780415
Labeler code
0378
Product ID
0378-0415_70e22ff5-bb2b-4a03-b0c3-63148f56f22b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA085762
Marketing category
ANDA
Marketing start
1977-11-17
Marketing end
2024-03-31
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
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0415-01EA - Each0378-0415a46f8bb0-9326-4512-b6ab-931fddae8d4e12012-07-24
0378-0415-10EA - Each0378-041506c64298-2dad-41fb-b552-9a67bef4865f12012-07-24
0378-0415-77EA - Each0378-041504e1e52f-438c-4e2f-a26f-8204fbf7cc1512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REDPHARM DRUG, INC.]3
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REDPHARM DRUG, INC.]3
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REDPHARM DRUG, INC.]3
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REDPHARM DRUG, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REDPHARM DRUG, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REDPHARM DRUG, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REDPHARM DRUG, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REDPHARM DRUG, INC.]3
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]1
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]1
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]1
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
DIPHENOXYLATE HYDROCHLORIDEACTIVE INGREDIENTW24OD7YW48DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]1
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]1
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]1
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ATROPINEACTIVE MOIETY7C0697DR9IDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APOTHECA, INC]1
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]1
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
DIPHENOXYLATEACTIVE MOIETY73312P173GDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [DISPENSING SOLUTIONS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [PHYSICIANS TOTAL CARE, INC.]1

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
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN4606e3af-badc-4584-855e-3993a915467c12
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD4606e3af-badc-4584-855e-3993a915467c12
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN0eaf5362-9df0-40a1-af8b-84a1e65ae9cf8
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD0eaf5362-9df0-40a1-af8b-84a1e65ae9cf8
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN7a7ff864-f4e4-48da-94c2-6ccbc30de49c3
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD7a7ff864-f4e4-48da-94c2-6ccbc30de49c3
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN18a96a2c-404f-4234-adf4-6411d2877aae2
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD18a96a2c-404f-4234-adf4-6411d2877aae2
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN47b65bb8-8501-448c-aecd-b41c8efb42411
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN51536429-1544-4bdd-9cf7-7753d29788411
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN787f49c7-3726-4eee-87f0-0d6ab8fc5f3c1
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD47b65bb8-8501-448c-aecd-b41c8efb42411
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD51536429-1544-4bdd-9cf7-7753d29788411
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD787f49c7-3726-4eee-87f0-0d6ab8fc5f3c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0415-0100378041501100 TABLET in 1 BOTTLE, PLASTIC (0378-0415-01) 100 tablet1977-11-172024-03-31NoNoCurrent
0378-0415-10003780415101000 TABLET in 1 BOTTLE, PLASTIC (0378-0415-10) 1000 tablet1977-11-172024-03-31NoNoCurrent
0378-0415-770037804157790 TABLET in 1 BOTTLE, PLASTIC (0378-0415-77) 90 tablet1977-11-172024-03-31NoNoCurrent