NDC 0597-0121

Maximum Strength Zantac

Ranitidine

Maximum Strength Zantac is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals Inc.. The primary component is Ranitidine Hydrochloride.

Product ID0597-0121_75260c56-23f1-66dd-10ba-4728a73e5bf9
NDC0597-0121
Product TypeHuman Otc Drug
Proprietary NameMaximum Strength Zantac
Generic NameRanitidine
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2006-12-21
Marketing CategoryNDA / NDA
Application NumberNDA021698
Labeler NameBoehringer Ingelheim Pharmaceuticals Inc.
Substance NameRANITIDINE HYDROCHLORIDE
Active Ingredient Strength150 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0597-0121-01

2 BOTTLE in 1 CARTON (0597-0121-01) > 50 TABLET, COATED in 1 BOTTLE
Marketing Start Date2006-12-21
Marketing End Date2021-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0597-0121-01 [00597012101]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-90 [00597012190]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-95 [00597012195]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2012-06-08

NDC 0597-0121-38 [00597012138]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-24 [00597012124]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-11 [00597012111]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-66 [00597012166]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-50 [00597012150]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-09 [00597012109]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-85 [00597012185]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-82 [00597012182]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-80 [00597012180]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-68 [00597012168]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-08 [00597012108]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-78 [00597012178]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-94 [00597012194]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-64 [00597012164]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

NDC 0597-0121-06 [00597012106]

Maximum Strength Zantac TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021698
Product TypeHUMAN OTC DRUG
Marketing Start Date2006-12-21
Marketing End Date2021-11-30

Drug Details

Active Ingredients

IngredientStrength
RANITIDINE HYDROCHLORIDE150 mg/1

OpenFDA Data

SPL SET ID:4da36a98-7363-4a8a-9bfe-5dfa7d2e1268
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 827189
  • 198191
  • NDC Crossover Matching brand name "Maximum Strength Zantac" or generic name "Ranitidine"

    NDCBrand NameGeneric Name
    0597-0121Maximum Strength Zantacranitidine
    10202-8527 Select Acid ReducerRanitidine
    0904-6350Acid ReducerRanitidine
    0113-7950basic care acid reducerRanitidine
    0113-7852basic care acid reducer 150Ranitidine
    0113-7876basic care acid reducer 75Ranitidine
    0113-0852Good Sense Acid ReducerRanitidine
    0113-0876Good Sense Acid ReducerRanitidine
    10202-712MAXIMUM STRENGTH RANITIDINERanitidine
    0121-0727RanitidineRANITIDINE
    0121-4727RanitidineRANITIDINE
    0172-4357RanitidineRanitidine
    0172-4358RanitidineRanitidine
    0363-0352RanitidineRanitidine
    0440-8300RanitidineRanitidine
    0440-8305RanitidineRanitidine
    0615-4513RanitidineRanitidine
    0615-4514RanitidineRanitidine
    0615-8021RanitidineRanitidine
    0781-6087RanitidineRanitidine
    0904-6349RanitidineRanitidine
    0904-6716RanitidineRanitidine
    0904-6921RanitidineRanitidine
    10544-056RanitidineRanitidine
    10544-438RanitidineRanitidine
    10544-516RanitidineRanitidine
    11673-849RanitidineRanitidine
    0904-6715ranitidine 75Ranitidine
    11673-023up and up ranitidineRanitidine
    0363-0852wal zan 150Ranitidine
    0363-0950wal zan 150Ranitidine
    0363-1876wal zan 75Ranitidine
    0363-0362Wal-ZanRanitidine
    0597-0122Zantac 75ranitidine
    0597-0120Zantac Maximum Strength 150 Cool Mintranitidine

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.