NDC 62980-515

Ranitidine 300 mg

Ranitidine

Ranitidine 300 mg is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Vivimed Labs Limited. The primary component is Ranitidine Hydrochloride.

Product ID62980-515_66489df3-56c1-4b61-b8a4-f8c2a49f4341
NDC62980-515
Product TypeHuman Prescription Drug
Proprietary NameRanitidine 300 mg
Generic NameRanitidine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA210010
Labeler NameVivimed Labs Limited
Substance NameRANITIDINE HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 62980-515-05

35 TABLET, FILM COATED in 1 CARTON (62980-515-05)
Marketing Start Date2019-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62980-515-02 [62980051502]

Ranitidine 300 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210010
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01
Marketing End Date2019-11-26

NDC 62980-515-01 [62980051501]

Ranitidine 300 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210010
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01
Marketing End Date2019-11-26

NDC 62980-515-03 [62980051503]

Ranitidine 300 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210010
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01
Marketing End Date2019-11-26

NDC 62980-515-05 [62980051505]

Ranitidine 300 mg TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210010
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01
Marketing End Date2019-11-26

Drug Details

Active Ingredients

IngredientStrength
RANITIDINE HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:bbf8c05d-0c45-4d6c-a787-41452d35fda8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198193
  • 198191
  • Pharmacological Class

    • Histamine H2 Receptor Antagonists [MoA]
    • Histamine-2 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "Ranitidine 300 mg" or generic name "Ranitidine"

    NDCBrand NameGeneric Name
    62980-515Ranitidine 300 mgRanitidine 300 mg
    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
    0597-0121Maximum Strength Zantacranitidine
    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

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