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16837-855 NDC - PEPCID AC (FAMOTIDINE)

Drug Information

Product NDC: 16837-855

Proprietary Name: PEPCID AC

Non Proprietary Name: Famotidine

Active Ingredient(s):
  • 20 mg/1 FAMOTIDINE


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

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

Labeler Information

Labeler Name: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Product Type: HUMAN OTC DRUG
FDA Application Number: NDA020325
Marketing Category: NDA
Start Marketing Date:9/1/2003

Package Information

No. Package Code Package Description Billing Unit
116837-855-051 BLISTER PACK in 1 CARTON (16837-855-05) / 5 TABLET, FILM COATED in 1 BLISTER PACK
216837-855-091 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
316837-855-121 BOTTLE, PLASTIC in 1 CARTON (16837-855-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
416837-855-131 TABLET, FILM COATED in 1 POUCH (16837-855-13)
516837-855-145 BLISTER PACK in 1 CARTON (16837-855-14) / 5 TABLET, FILM COATED in 1 BLISTER PACKEA
616837-855-151 BOTTLE, PLASTIC in 1 CARTON (16837-855-15) / 35 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
716837-855-161 BOTTLE, PLASTIC in 1 CARTON (16837-855-16) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
816837-855-171 BOTTLE, PLASTIC in 1 CARTON (16837-855-17) / 65 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
916837-855-181 BOTTLE, PLASTIC in 1 CARTON (16837-855-18) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1016837-855-191 BLISTER PACK in 1 CARTON (16837-855-19) / 8 TABLET, FILM COATED in 1 BLISTER PACK
1116837-855-202 CARTON in 1 PACKAGE (16837-855-20) / 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
1216837-855-405 BLISTER PACK in 1 CARTON (16837-855-40) / 8 TABLET, FILM COATED in 1 BLISTER PACK
1316837-855-491 BOTTLE, PLASTIC in 1 CARTON (16837-855-49) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1416837-855-501 BOTTLE, PLASTIC in 1 CARTON (16837-855-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
1516837-855-5112 BLISTER PACK in 1 CARTON (16837-855-51) / 5 TABLET, FILM COATED in 1 BLISTER PACK
1616837-855-5250 POUCH in 1 TRAY (16837-855-52) / 1 TABLET, FILM COATED in 1 POUCH
1716837-855-651 BOTTLE, PLASTIC in 1 CARTON (16837-855-65) / 65 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1816837-855-671 BOTTLE, PLASTIC in 1 CARTON (16837-855-67) / 65 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
1916837-855-701 BOTTLE, PLASTIC in 1 CARTON (16837-855-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2016837-855-751 BOTTLE, PLASTIC in 1 CARTON (16837-855-75) / 75 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
2116837-855-801 BOTTLE, PLASTIC in 1 CARTON (16837-855-80) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2216837-855-851 BOTTLE, PLASTIC in 1 CARTON (16837-855-85) / 85 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2316837-855-90125 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (16837-855-90)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC16837-855The 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 NAMEPEPCID ACThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXMaximum StrengthA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEFamotidineThe 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 DATE9/1/2003This 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 NUMBERNDA020325This 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 NAMEJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEFAMOTIDINEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH20 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESHistamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] 

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This page was last updated on: 2/1/2023
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