Diphenoxylate Hydrochloride and Atropine Sulfate

Product NDC
21695-688
11-digit product format
216950688
Labeler code
21695
Product ID
21695-688_787f49c7-3726-4eee-87f0-0d6ab8fc5f3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA085762
Marketing category
ANDA
Marketing start
2009-11-30
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
E
Listing certified through
2017-12-31
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
21695-688-152019-09-24C16284748780-1934fe258-4b3f-48b1-e053-8cdaa90a720aDiphenoxylate Hydrochloride
21695-688-202019-09-24C16284748780-1934fe258-4b3f-48b1-e053-8cdaa90a720aDiphenoxylate Hydrochloride
21695-688-302019-09-24C16284748780-1934fe258-4b3f-48b1-e053-8cdaa90a720aDiphenoxylate Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-688-15Diphenoxylate Hydrochloride and Atropine Sulfate15 in 1 BOTTLE, PLASTICTABLET151
21695-688-20Diphenoxylate Hydrochloride and Atropine Sulfate20 in 1 BOTTLE, PLASTICTABLET201
21695-688-30Diphenoxylate 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
21695-688-15EA - Each21695-68831f495a1-6c16-4fda-8ef3-de76e9dc618812012-07-24
21695-688-20EA - Each21695-68805b6eed9-48d1-49f1-9c80-e1f14e853eaa12012-07-24
21695-688-30EA - Each21695-688305c7746-2506-4232-a615-35be5f80056b12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-688DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20101119_787f49c7-3726-4eee-87f0-0d6ab8fc5f3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 TabletSCD787f49c7-3726-4eee-87f0-0d6ab8fc5f3c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-688-152169506881515 in 1 BOTTLE, PLASTICHistorical
21695-688-202169506882020 in 1 BOTTLE, PLASTICHistorical
21695-688-302169506883030 in 1 BOTTLE, PLASTICHistorical