30698-460 NDC - LOPRESSOR HCT ()

Drug Information

  • Product NDC: 30698-460
  • Proprietary Name: Lopressor HCT
  • Non Proprietary Name:
  • Active Ingredient(s): 12.5 mg/1 METOPROLOL TARTRATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Adrenergic beta-Antagonists [MoA]; beta-Adrenergic Blocker [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Validus Pharmaceuticals LLC
Product Type:
FDA Application Number: NDA018303
Marketing Category: NDA
Start Marketing Date:12/31/1984
End Marketing Date:1/30/2024

Package Information

No. Package Code Package Description Billing Unit
130698-460-01100 TABLET in 1 BOTTLE (30698-460-01)EA
230698-460-0330 TABLET in 1 BOTTLE (30698-460-03)
330698-460-101000 TABLET in 1 BOTTLE (30698-460-10)

NDC Record

Field Name Field Value Definition
PRODUCT NDC30698-460The 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.
PROPRIETARY NAMELopressor HCTThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE12/31/1984This 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 NUMBERNDA018303This 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 NAMEValidus Pharmaceuticals LLCName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC30698-460The 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.
PROPRIETARY NAMELOPRESSORThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/28/2025This 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 NUMBERNDA218698This 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 NAMEVALIDUS PHARMACEUTICALS LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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