49629-026 NDC - EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

Drug Information

  • Product NDC: 49629-026
  • Proprietary Name:
  • Non Proprietary Name: emtricitabine and tenofovir alafenamide fumarate
  • Active Ingredient(s): 200 mg/1 EMTRICITABINE; 25 mg/1 TENOFOVIR ALAFENAMIDE FUMARATE
  • Administration Route(s):
  • Dosage Form(s): TABLET

Labeler Information

Field Name Field Value
Labeler Name: Rottendorf Pharma GmbH
Product Type: DRUG FOR FURTHER PROCESSING
FDA Application Number:
Marketing Category: DRUG FOR FURTHER PROCESSING
Start Marketing Date:4/4/2016

Package Information

No. Package Code Package Description Billing Unit
149629-026-0180 BOTTLE, PLASTIC in 1 CARTON (49629-026-01) / 30 TABLET in 1 BOTTLE, PLASTIC
249629-026-991 BAG in 1 DRUM (49629-026-99) / 55202 TABLET in 1 BAG

NDC Record

Field Name Field Value Definition
PRODUCT NDC49629-026The 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 NAMEDRUG FOR FURTHER PROCESSINGThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEemtricitabine and tenofovir alafenamide fumarateThis is the date that the labeler indicates was the start of its marketing of the drug product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE4/4/2016This 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.
MARKETING CATEGORY NAMEDRUG FOR FURTHER PROCESSINGName of Company corresponding to the labeler code segment of the Product NDC.
LABELER NAMERottendorf Pharma GmbHName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEEMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATEAn 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 STRENGTH200; 25 
ACTIVE INGRED UNITmg/1; mg/1 

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This page was last updated on: 1/2/2026

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