FDA.reportPublic FDA data

Diphenoxylate hydrochloride and atropine sulfate

Product NDC
62135-618
11-digit product format
621350618
Labeler code
62135
Product ID
62135-618_459bb891-bb8e-c6b4-e063-6294a90a676a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diphenoxylate hydrochloride and atropine sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA207128
Marketing category
ANDA
Marketing start
2020-10-21
Substance
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Active strength
.025; 2.5 mg/1; mg/1
Pharmacologic classes
Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenoxylate hydrochloride and atropine sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.025 mg/1
DIPHENOXYLATE HYDROCHLORIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5, W24OD7YW48
Rxcui1190572

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-618-12Diphenoxylate hydrochloride and atropine sulfate120 in 1 BOTTLETABLET1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-618-12EA - Each62135-6187ded4780-54b6-44b3-a52f-4be9a57f6f9712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-618DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE TABLET [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 1 package rows20241012_240b537e-ff9b-45e3-9398-584372bd707a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190572diphenoxylate HCl 2.5 MG / atropine sulfate 0.025 MG Oral TabletPSN240b537e-ff9b-45e3-9398-584372bd707a4
1190572atropine sulfate 0.025 MG / diphenoxylate hydrochloride 2.5 MG Oral TabletSCD240b537e-ff9b-45e3-9398-584372bd707a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-618-1262135061812120 TABLET in 1 BOTTLE (62135-618-12) 120 tablet2022-06-080000-00-00NoNoCurrent