70518-2107 NDC - VENLAFAXINE HYDROCHLORIDE

Drug Information

  • Product NDC: 70518-2107
  • Proprietary Name: Venlafaxine Hydrochloride
  • Non Proprietary Name: Venlafaxine Hydrochloride
  • Active Ingredient(s): 75 mg/1 VENLAFAXINE HYDROCHLORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE, EXTENDED RELEASE
  • Pharmacy Class(es): Norepinephrine Uptake Inhibitors [MoA]; Serotonin Uptake Inhibitors [MoA]; Serotonin and Norepinephrine Reuptake Inhibitor [EPC]

Labeler Information

Field Name Field Value
Labeler Name: REMEDYREPACK INC.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA200834
Marketing Category: ANDA
Start Marketing Date:5/23/2019

Package Information

No. Package Code Package Description Billing Unit
170518-2107-030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2107-0)
270518-2107-130 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2107-1)
370518-2107-290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2107-2)
470518-2107-330 POUCH in 1 BOX (70518-2107-3) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-2107-4)
570518-2107-530 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2107-5)

NDC Record

Field Name Field Value Definition
PRODUCT NDC70518-2107The 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 NAMEVenlafaxine HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEVenlafaxine HydrochlorideThe 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.
DOSAGE FORM NAMECAPSULE, EXTENDED RELEASEIndicates 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.
ROUTE NAMEORALThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE5/23/2019The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
MARKETING CATEGORY NAMEANDAThe translation of the dosage form Code submitted by the firm.
APPLICATION NUMBERANDA200834This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAMEREMEDYREPACK INC.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEVENLAFAXINE HYDROCHLORIDEAn 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 STRENGTH75Name of Company corresponding to the labeler code segment of the Product NDC.
ACTIVE INGRED UNITmg/1 
PHARM CLASSESNorepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC] 

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This page was last updated on: 12/19/2025

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