rabeprazole sodium

Generic: rabeprazole sodium

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rabeprazole sodium
Generic Name rabeprazole sodium
Labeler asclemed usa, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

rabeprazole sodium 20 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-818
Product ID 76420-818_4ad5e40b-0272-c104-e063-6294a90a8237
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208644
Listing Expiration 2027-12-31
Marketing Start 2018-04-27

Pharmacologic Class

Classes
proton pump inhibitor [epc] proton pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420818
Hyphenated Format 76420-818

Supplemental Identifiers

RxCUI
854868
UNII
3L36P16U4R

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rabeprazole sodium (source: ndc)
Generic Name rabeprazole sodium (source: ndc)
Application Number ANDA208644 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-30)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-60)
  • 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-90)
source: ndc

Packages (3)

76420-818-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-30) 76420-818-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-60) 76420-818-90 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-90)

Ingredients (1)

rabeprazole sodium (20 mg/1)

Linked Drug Pages (1)

Rabeprazole Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4ad5e40b-0272-c104-e063-6294a90a8237", "openfda": {"unii": ["3L36P16U4R"], "rxcui": ["854868"], "spl_set_id": ["3b6a25c2-fb61-4c86-9988-c6ffac7939c4"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-30)", "package_ndc": "76420-818-30", "marketing_start_date": "20240625"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-60)", "package_ndc": "76420-818-60", "marketing_start_date": "20240625"}, {"sample": false, "description": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-818-90)", "package_ndc": "76420-818-90", "marketing_start_date": "20240625"}], "brand_name": "Rabeprazole Sodium", "product_id": "76420-818_4ad5e40b-0272-c104-e063-6294a90a8237", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "76420-818", "generic_name": "Rabeprazole Sodium", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rabeprazole Sodium", "active_ingredients": [{"name": "RABEPRAZOLE SODIUM", "strength": "20 mg/1"}], "application_number": "ANDA208644", "marketing_category": "ANDA", "marketing_start_date": "20180427", "listing_expiration_date": "20271231"}