54569-0118 NDC - DOXYCYCLINE HYCLATE ()

Drug Information

  • Product NDC: 54569-0118
  • Proprietary Name: Doxycycline Hyclate
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: A-S Medication Solutions LLC
Product Type:
FDA Application Number: ANDA062421
Marketing Category: ANDA
Start Marketing Date:2/2/1983

Package Information

No. Package Code Package Description Billing Unit
154569-0118-010 TABLET in 1 BOTTLE, PLASTIC (54569-0118-0)EA
254569-0118-114 TABLET in 1 BOTTLE, PLASTIC (54569-0118-1)EA
354569-0118-27 TABLET in 1 BOTTLE, PLASTIC (54569-0118-2)EA
454569-0118-320 TABLET in 1 BOTTLE, PLASTIC (54569-0118-3)EA
554569-0118-528 TABLET in 1 BOTTLE, PLASTIC (54569-0118-5)EA
654569-0118-630 TABLET in 1 BOTTLE, PLASTIC (54569-0118-6)EA
754569-0118-860 TABLET in 1 BOTTLE, PLASTIC (54569-0118-8)EA
854569-0118-9100 TABLET in 1 BOTTLE, PLASTIC (54569-0118-9)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC54569-0118The 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 NAMEDoxycycline HyclateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE2/2/1983This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA062421This 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 NAMEA-S Medication Solutions LLCName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 4/4/2025

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