aciphex

Generic: rabeprazole sodium

Labeler: waylis therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name aciphex
Generic Name rabeprazole sodium
Labeler waylis therapeutics llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

rabeprazole sodium 20 mg/1

Manufacturer
Waylis Therapeutics LLC

Identifiers & Regulatory

Product NDC 80725-243
Product ID 80725-243_cc6cb214-ac28-4c8b-9b57-7635ef896038
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020973
Listing Expiration 2027-12-31
Marketing Start 2022-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80725243
Hyphenated Format 80725-243

Supplemental Identifiers

RxCUI
854868 854870
UPC
0380725243303
UNII
3L36P16U4R

Packaging Origin

Original Packager
true

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 aciphex (source: ndc)
Generic Name rabeprazole sodium (source: ndc)
Application Number NDA020973 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80725-243-30)
source: ndc

Packages (1)

80725-243-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80725-243-30)

Ingredients (1)

rabeprazole sodium (20 mg/1)

Linked Drug Pages (1)

Aciphex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cc6cb214-ac28-4c8b-9b57-7635ef896038", "openfda": {"upc": ["0380725243303"], "unii": ["3L36P16U4R"], "rxcui": ["854868", "854870"], "spl_set_id": ["1eb38279-0237-4967-be7a-c53a826c1138"], "manufacturer_name": ["Waylis Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80725-243-30)", "package_ndc": "80725-243-30", "marketing_start_date": "20231201"}], "brand_name": "Aciphex", "product_id": "80725-243_cc6cb214-ac28-4c8b-9b57-7635ef896038", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "80725-243", "generic_name": "rabeprazole sodium", "labeler_name": "Waylis Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aciphex", "active_ingredients": [{"name": "RABEPRAZOLE SODIUM", "strength": "20 mg/1"}], "application_number": "NDA020973", "marketing_category": "NDA", "marketing_start_date": "20220515", "listing_expiration_date": "20271231"}