NDC 21695-048

ORGAN-I NR

Guaifenesin

ORGAN-I NR is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Guaifenesin.

Product ID21695-048_96c89e90-4db0-49df-bf0e-62991cc1dadb
NDC21695-048
Product TypeHuman Otc Drug
Proprietary NameORGAN-I NR
Generic NameGuaifenesin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2002-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRebel Distributors Corp
Substance NameGUAIFENESIN
Active Ingredient Strength200 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-048-40

40 TABLET in 1 BOTTLE, PLASTIC (21695-048-40)
Marketing Start Date2002-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-048-30 [21695004830]

ORGAN-I NR TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2002-07-01
Inactivation Date2019-09-24

NDC 21695-048-40 [21695004840]

ORGAN-I NR TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2011-11-07
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN200 mg/1

OpenFDA Data

SPL SET ID:17e6ba6d-a80f-4e8a-8435-8dca701f1c3a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197741
  • NDC Crossover Matching brand name "ORGAN-I NR" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    68151-1929ORGAN-I NRORGAN-I NR
    21695-048ORGAN-I NRORGAN-I NR
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    0363-0071MucusGuaifenesin
    0363-0074MucusGuaifenesin
    0363-0532Mucus ReliefGuaifenesin
    0363-0325mucus relief erGuaifenesin
    0031-9303Robitussin Direct Chest Congestionguaifenesin
    0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
    0113-2061tussinGuaifenesin
    0363-0310wal tussinGuaifenesin

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