NDC 50382-009

Mineral Oil

Mineral Oil

Mineral Oil is a Rectal Enema in the Human Otc Drug category. It is labeled and distributed by Galentic Pharma (india) Priva Te Limited. The primary component is Mineral Oil.

Product ID50382-009_8b6f01c2-5a58-4818-b9f7-22bad9bddbd4
NDC50382-009
Product TypeHuman Otc Drug
Proprietary NameMineral Oil
Generic NameMineral Oil
Dosage FormEnema
Route of AdministrationRECTAL
Marketing Start Date2013-08-07
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart334
Labeler NameGalentic Pharma (India) Priva Te Limited
Substance NameMINERAL OIL
Active Ingredient Strength118 g/118mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 50382-009-01

118 mL in 1 BOTTLE (50382-009-01)
Marketing Start Date2013-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50382-009-01 [50382000901]

Mineral Oil ENEMA
Marketing CategoryOTC monograph not final
Application Numberpart334
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-07
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
MINERAL OIL118 g/118mL

OpenFDA Data

SPL SET ID:d6c46406-25b1-42fe-be1b-34d3ab6577a6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205121

    • NDC Crossover Matching brand name "Mineral Oil" or generic name "Mineral Oil"

    NDCBrand NameGeneric Name
    0363-0360Mineral OilMineral Oil
    0363-0831Mineral OilMineral Oil
    0363-0834Mineral OilMineral Oil
    0574-0618Mineral OilMineral Oil
    11673-034Mineral oilMineral oil
    11673-831Mineral OilMineral Oil
    11822-0603Mineral OilMineral Oil
    11822-3340Mineral OilMineral Oil
    11822-3601Mineral OilMineral Oil
    15127-334Mineral oilMineral oil
    15127-831Mineral OilMineral Oil
    68788-7055Mineral OilMineral Oil
    69256-334Mineral oilMineral oil
    21130-831Mineral OilMineral Oil
    21695-681Mineral OilMineral Oil
    30142-831Mineral OilMineral Oil
    36800-931Mineral OilMineral Oil
    36800-334Mineral OilMineral Oil
    37205-831Mineral OilMineral Oil
    37012-831Mineral OilMineral Oil
    41163-831Mineral OilMineral Oil
    41190-831Mineral OilMineral Oil
    41520-334Mineral OilMineral Oil
    41250-831Mineral OilMineral Oil
    41520-877Mineral OilMineral Oil
    46122-395Mineral OilMineral Oil
    49035-035Mineral oilMineral oil
    49580-0334Mineral oilMineral oil
    49738-334Mineral oilMineral oil
    50382-009Mineral OilMineral Oil
    50804-831Mineral OilMineral Oil
    54162-190Mineral OilMineral Oil
    54162-175Mineral oilMineral oil
    55312-831Mineral OilMineral Oil
    55316-831Mineral OilMineral Oil
    55315-334Mineral OilMineral Oil
    55301-831Mineral OilMineral Oil
    55319-634Mineral OilMineral Oil
    55910-831Mineral OilMineral Oil
    56062-334Mineral OilMineral Oil
    61767-001Mineral OilMineral Oil
    61715-163Mineral OilMineral Oil
    63868-938Mineral oilMineral oil
    63941-334Mineral oilMineral oil
    0132-0301FLEETMineral Oil
    0132-0556FLEETMineral Oil
    0395-1685Humco Mineral Oil HeavyMineral Oil
    0395-1673Humco Mineral Oil LightMineral Oil
    0395-9135Mineral Oil HeavyMineral Oil
    0363-0006Mineral Oil Lubricant Laxativemineral oil
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.