52565-101 NDC - ZANTAC (RANITIDINE HYDROCHLORIDE)

Drug Information

Product NDC: 52565-101

Proprietary Name: ZANTAC

Non Proprietary Name: ranitidine hydrochloride

Active Ingredient(s):
  • 25 mg/mL RANITIDINE HYDROCHLORIDE


Administration Route(s): INTRAMUSCULAR; INTRAVENOUS

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Histamine H2 Receptor Antagonists [MoA];
  • Histamine-2 Receptor Antagonist [EPC]

Labeler Information

Labeler Name: Teligent Pharma, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA019090
Marketing Category: NDA
Start Marketing Date:8/23/2017

Package Information

No. Package Code Package Description Billing Unit
152565-101-2525 VIAL in 1 CARTON (52565-101-25) > 2 mL in 1 VIAL

NDC Record

Field Name Field Value Definition
PRODUCT NDC52565-101The 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 PRESCRIPTION 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 NAMEZANTACThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEranitidine hydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAMUSCULAR; INTRAVENOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/23/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA019090This 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 NAMETeligent Pharma, Inc.Name 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.
ACTIVE NUMERATOR STRENGTH25 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESHistamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC] 

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This page was last updated on: 11/18/2019