sunmark anti diarrheal

Product NDC
49348-529
11-digit product format
493480529
Labeler code
49348
Product ID
49348-529_627a7e28-0bf0-4e01-b6a2-7e7e7e2ebbbd
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA075232
Marketing category
ANDA
Marketing start
2003-06-27
Marketing end
0000-00-00
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-529-02EA - Each49348-529d8bd1f70-7809-45e0-9f3e-a870c078363212012-07-24
49348-529-04EA - Each49348-52992a0e354-360e-45b2-b29d-b03467dac0a012012-07-24
49348-529-08EA - Each49348-5297f92f51e-900e-48f0-b6de-22df6848ea1712012-07-24
49348-529-34EA - Each49348-5298b0411d5-53ae-4cce-aa0d-a095658bd8c212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-529SUNMARK ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]7Legacy NDC20241225_5c1591f8-9291-4062-8ba9-fc9507963d93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNa732a67c-bce1-4521-9df4-69709fdf537d1
978010loperamide hydrochloride 2 MG Oral TabletSCDa732a67c-bce1-4521-9df4-69709fdf537d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-529-024934805290212 BLISTER PACK in 1 CARTON (49348-529-02) > 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2003-08-210000-00-00NoNoCurrent
49348-529-044934805290424 BLISTER PACK in 1 CARTON (49348-529-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2009-07-150000-00-00NoNoCurrent
49348-529-08493480529081 BOTTLE in 1 CARTON (49348-529-08) > 48 TABLET, FILM COATED in 1 BOTTLE1 bottle2003-06-270000-00-00NoNoCurrent
49348-529-34493480529341 BOTTLE in 1 CARTON (49348-529-34) > 96 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-11-160000-00-00NoNoCurrent