FDA.reportPublic FDA data

Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
67544-021
11-digit product format
675440021
Labeler code
67544
Product ID
67544-021_f2c3a3a3-2b0d-46eb-94fb-2b708690c0eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA085762
Marketing category
ANDA
Marketing start
2010-11-30
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
2019-12-31
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
67544-021-302020-01-31C16284748780-19d75b9d0-7b8b-f424-e053-dadaa90a57ce18a96a2c-404f-4234-adf4-6411d2877aae
67544-021-402020-01-31C16284748780-19d75b9d0-7b8b-f424-e053-dadaa90a57ce18a96a2c-404f-4234-adf4-6411d2877aae
67544-021-532020-01-31C16284748780-19d75b9d0-7b8b-f424-e053-dadaa90a57ce18a96a2c-404f-4234-adf4-6411d2877aae
67544-021-602020-01-31C16284748780-19d75b9d0-7b8b-f424-e053-dadaa90a57ce18a96a2c-404f-4234-adf4-6411d2877aae
67544-021-702020-01-31C16284748780-19d75b9d0-7b8b-f424-e053-dadaa90a57ce18a96a2c-404f-4234-adf4-6411d2877aae
67544-021-802020-01-31C16284748780-19d75b9d0-7b8b-f424-e053-dadaa90a57ce18a96a2c-404f-4234-adf4-6411d2877aae
67544-021-902020-01-31C16284748780-19d75b9d0-7b8b-f424-e053-dadaa90a57ce18a96a2c-404f-4234-adf4-6411d2877aae

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-021-30Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLE, PLASTICTABLET302
67544-021-40Diphenoxylate Hydrochloride and Atropine Sulfate40 in 1 BOTTLE, PLASTICTABLET402
67544-021-53Diphenoxylate Hydrochloride and Atropine Sulfate60 in 1 BOTTLE, PLASTICTABLET602
67544-021-60Diphenoxylate Hydrochloride and Atropine Sulfate90 in 1 BOTTLE, PLASTICTABLET902
67544-021-70Diphenoxylate Hydrochloride and Atropine Sulfate120 in 1 BOTTLE, PLASTICTABLET1202
67544-021-80Diphenoxylate Hydrochloride and Atropine Sulfate180 in 1 BOTTLE, PLASTICTABLET1802
67544-021-90Diphenoxylate Hydrochloride and Atropine Sulfate240 in 1 BOTTLE, PLASTICTABLET2402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-021-30EA - Each67544-021059fb1c0-5424-4774-8526-1b320c8abd0d12013-06-04
67544-021-40EA - Each67544-021fc4d326d-5e09-43e8-90f2-50b1736215c612013-06-04
67544-021-53EA - Each67544-02168b95c1b-5772-4d96-813f-4ba9b891d3a212013-06-04
67544-021-60EA - Each67544-021f3a91e4a-08cf-45e3-b15f-6307d1d28e9112013-06-04
67544-021-70EA - Each67544-0219794aec5-23c1-469e-b4bd-388910620f0212013-06-04
67544-021-80EA - Each67544-021dbac5c91-80e5-48a8-a9f3-1fa6db2b771812013-07-02
67544-021-90EA - Each67544-021a7fb6c9b-155d-4792-b905-47b53b8b0df412013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-021DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 7 package rows20140415_18a96a2c-404f-4234-adf4-6411d2877aae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-021-306754400213030 in 1 BOTTLE, PLASTICHistorical
67544-021-406754400214040 in 1 BOTTLE, PLASTICHistorical
67544-021-536754400215360 in 1 BOTTLE, PLASTICHistorical
67544-021-606754400216090 in 1 BOTTLE, PLASTICHistorical
67544-021-7067544002170120 in 1 BOTTLE, PLASTICHistorical
67544-021-8067544002180180 in 1 BOTTLE, PLASTICHistorical
67544-021-9067544002190240 in 1 BOTTLE, PLASTICHistorical