NDC 0378-2100

Loperamide Hydrochloride

Loperamide Hydrochloride

Loperamide Hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Loperamide Hydrochloride.

Product ID0378-2100_1d930a39-cff7-4fa6-b2bf-9f0bc6725340
NDC0378-2100
Product TypeHuman Prescription Drug
Proprietary NameLoperamide Hydrochloride
Generic NameLoperamide Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1991-09-18
Marketing CategoryANDA / ANDA
Application NumberANDA072741
Labeler NameMylan Pharmaceuticals Inc.
Substance NameLOPERAMIDE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0378-2100-01

100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2100-01)
Marketing Start Date1991-09-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-2100-01 [00378210001]

Loperamide Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA072741
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1991-09-18

NDC 0378-2100-05 [00378210005]

Loperamide Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA072741
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1991-09-18

Drug Details

Active Ingredients

IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:72a7ae47-cdf3-4949-b9f8-f29b153f787f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 978006

    • Pharmacological Class

    • Opioid Agonist [EPC]
    • Opioid Agonists [MoA]
    • Opioid Agonist [EPC]
    • Opioid Agonists [MoA]

    NDC Crossover Matching brand name "Loperamide Hydrochloride" or generic name "Loperamide Hydrochloride"

    NDCBrand NameGeneric Name
    0093-0311Loperamide HydrochlorideLoperamide Hydrochloride
    0113-7224loperamide hydrochlorideLoperamide HCl
    0363-0645loperamide hydrochlorideloperamide HCl
    0363-1645loperamide hydrochlorideloperamide HCl
    0378-2100Loperamide Hydrochlorideloperamide hydrochloride
    0615-0362Loperamide Hydrochlorideloperamide hydrochloride
    0615-8012Loperamide HydrochlorideLoperamide Hydrochloride
    0615-8087Loperamide Hydrochlorideloperamide hydrochloride
    0904-6256loperamide hydrochlorideloperamide HCl
    0904-6836loperamide hydrochlorideloperamide HCl
    11822-1645loperamide hydrochlorideloperamide HCl
    11822-5519loperamide hydrochlorideloperamide HCl
    15127-338Loperamide HydrochlorideLoperamide Hydrochloride
    17856-0618Loperamide HydrochlorideLoperamide Hydrochloride
    68016-123Loperamide HydrochlorideLoperamide Hydrochloride
    68071-4075Loperamide HydrochlorideLoperamide Hydrochloride
    68094-108Loperamide HydrochlorideLoperamide Hydrochloride
    68094-107Loperamide HydrochlorideLoperamide Hydrochloride
    68151-0618Loperamide HydrochlorideLoperamide Hydrochloride
    68788-9079Loperamide HydrochlorideLoperamide Hydrochloride
    68788-9704loperamide hydrochlorideloperamide hydrochloride
    68788-9773Loperamide HydrochlorideLoperamide Hydrochloride
    68998-123Loperamide HydrochlorideLoperamide Hydrochloride
    69842-191Loperamide hydrochlorideLoperamide hydrochloride
    70518-0313Loperamide HydrochlorideLoperamide Hydrochloride
    70518-0052Loperamide HydrochlorideLoperamide Hydrochloride
    70518-0072Loperamide HydrochlorideLoperamide Hydrochloride
    70518-0893Loperamide HydrochlorideLoperamide Hydrochloride
    76413-314Loperamide hydrochlorideLoperamide hydrochloride
    21695-692Loperamide HydrochlorideLoperamide Hydrochloride
    30142-645Loperamide HydrochlorideLoperamide Hydrochloride
    33261-344Loperamide HydrochlorideLoperamide Hydrochloride
    35418-123Loperamide HydrochlorideLoperamide Hydrochloride
    37012-123Loperamide HydrochlorideLoperamide Hydrochloride
    37808-645Loperamide HydrochlorideLoperamide Hydrochloride
    41250-645loperamide hydrochlorideloperamide hydrochloride
    41250-813loperamide hydrochlorideloperamide hydrochloride
    42708-074Loperamide HydrochlorideLoperamide Hydrochloride
    43063-431Loperamide HydrochlorideLoperamide Hydrochloride
    43063-020Loperamide HydrochlorideLoperamide Hydrochloride
    46122-169Loperamide HydrochlorideLoperamide Hydrochloride
    50090-0461Loperamide HydrochlorideLoperamide Hydrochloride
    50090-2859Loperamide HydrochlorideLoperamide Hydrochloride
    50383-618Loperamide HydrochlorideLoperamide Hydrochloride
    50436-3974Loperamide HydrochlorideLoperamide Hydrochloride
    51079-690Loperamide HydrochlorideLoperamide Hydrochloride
    51660-123Loperamide HydrochlorideLoperamide Hydrochloride
    51655-547Loperamide hydrochlorideLoperamide hydrochloride
    53329-664Loperamide HydrochlorideLoperamide Hydrochloride
    53808-0707Loperamide HydrochlorideLoperamide Hydrochloride
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