NDC 61919-225

RABERPRAZOLE SODIUM D/R

Raberprazole Sodium D/r

RABERPRAZOLE SODIUM D/R is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Rabeprazole Sodium.

Product ID61919-225_5cc620a3-2d66-1ccf-e053-2a91aa0a1a91
NDC61919-225
Product TypeHuman Prescription Drug
Proprietary NameRABERPRAZOLE SODIUM D/R
Generic NameRaberprazole Sodium D/r
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2017-10-30
Marketing CategoryANDA / ANDA
Application NumberANDA202376
Labeler NameDIRECT RX
Substance NameRABEPRAZOLE SODIUM
Active Ingredient Strength20 mg/1
Pharm ClassesProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61919-225-60

60 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-225-60)
Marketing Start Date2019-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-225-30 [61919022530]

RABERPRAZOLE SODIUM D/R TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202376
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-30
Inactivation Date2020-01-31

NDC 61919-225-60 [61919022560]

RABERPRAZOLE SODIUM D/R TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202376
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-07

Drug Details

Active Ingredients

IngredientStrength
RABEPRAZOLE SODIUM20 mg/1

OpenFDA Data

SPL SET ID:5cc620a3-2d65-1ccf-e053-2a91aa0a1a91
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854868

    • Pharmacological Class

    • Proton Pump Inhibitor [EPC]
    • Proton Pump Inhibitors [MoA]
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