Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
33261-685
11-digit product format
332610685
Labeler code
33261
Product ID
33261-685_f88e1600-0e18-433a-90ae-1dcc7817bb59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals 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
33261-685-152020-01-31C16284748780-19d75b9d0-cd36-f424-e053-dadaa90a57ceDIPHENOX W ATROP 2 5 0 025MG FOR MYLAN
33261-685-302020-01-31C16284748780-19d75b9d0-cd36-f424-e053-dadaa90a57ceDIPHENOX W ATROP 2 5 0 025MG FOR MYLAN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-685-15Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BOTTLE, PLASTICTABLET151
33261-685-30Diphenoxylate Hydrochloride and Atropine Sulfate30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-685-15EA - Each33261-6850acee1ed-f479-4ac0-883b-c721b657b2e312015-10-02
33261-685-30EA - Each33261-685a1e9bbb8-2b63-45c8-8342-937731b883e112015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-685DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140106_51536429-1544-4bdd-9cf7-7753d2978841.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN51536429-1544-4bdd-9cf7-7753d29788411
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD51536429-1544-4bdd-9cf7-7753d29788411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-685-153326106851515 in 1 BOTTLE, PLASTICHistorical
33261-685-303326106853030 in 1 BOTTLE, PLASTICHistorical