46122-161 NDC - GOOD NEIGHBOR PHARMACY (SODIUM PHOSPHATE ENEMA)

Drug Information

Product NDC: 46122-161

Proprietary Name: Good Neighbor Pharmacy

Non Proprietary Name: Sodium Phosphate Enema

Active Ingredient(s):
  • 7 g/118mL SODIUM PHOSPHATE, DIBASIC;
  • 19 g/118mL SODIUM PHOSPHATE, MONOBASIC


Administration Route(s): RECTAL

Dosage Form(s): ENEMA

Labeler Information

Labeler Name: AMERISOURCEBERGEN DRUG CORPORATION
Product Type: HUMAN OTC DRUG
FDA Application Number: part334
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:3/1/2013

Package Information

No. Package Code Package Description Billing Unit
146122-161-281 BOTTLE in 1 CARTON (46122-161-28) > 133 mL in 1 BOTTLEML
246122-161-362 BOTTLE in 1 CARTON (46122-161-36) > 133 mL in 1 BOTTLEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC46122-161The 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 NAMEGood Neighbor PharmacyThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMESodium Phosphate EnemaThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEENEMAThe translation of the dosage form Code submitted by the firm.
ROUTE NAMERECTALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/1/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct 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 NUMBERpart334This 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 NAMEAMERISOURCEBERGEN DRUG CORPORATIONName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASICThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH7; 19 
ACTIVE INGRED UNITg/118mL; g/118mL 

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This page was last updated on: 9/13/2019