Drug Information

Product NDC: 30142-600

Proprietary Name: heartburn relief 150

Non Proprietary Name: Ranitidine

Active Ingredient(s):

Administration Route(s): ORAL


Labeler Information

Labeler Name: Kroger Company
Product Type: HUMAN OTC DRUG
FDA Application Number: ANDA091429
Marketing Category: ANDA
Start Marketing Date:8/31/2013

Package Information

No. Package Code Package Description Billing Unit
130142-600-0195 TABLET, FILM COATED in 1 BOTTLE (30142-600-01)
230142-600-021 BOTTLE in 1 CARTON (30142-600-02) > 24 TABLET, FILM COATED in 1 BOTTLE
330142-600-562 BOTTLE in 1 CARTON (30142-600-56) > 95 TABLET, FILM COATED in 1 BOTTLE
430142-600-711 BOTTLE in 1 CARTON (30142-600-71) > 50 TABLET, FILM COATED in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC30142-600The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEheartburn relief 150The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMERanitidineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/31/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA091429This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEKroger CompanyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMERANITIDINE HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

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This page was last updated on: 9/11/2020