0904-0430 NDC - DOXYCYCLINE ()

Drug Information

  • Product NDC: 0904-0430
  • Proprietary Name: Doxycycline
  • Non Proprietary Name:
  • Active Ingredient(s): 100 mg/1 DOXYCYCLINE HYCLATE
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): Tetracycline-class Drug [EPC]; Tetracyclines [CS]

Labeler Information

Field Name Field Value
Labeler Name: Major Pharmaceuticals
Product Type:
FDA Application Number: ANDA065095
Marketing Category: ANDA
Start Marketing Date:8/3/2004
End Marketing Date:9/30/2014

Package Information

No. Package Code Package Description Billing Unit
10904-0430-0430 BLISTER PACK in 1 CARTON (0904-0430-04) / 1 TABLET, COATED in 1 BLISTER PACKEA
20904-0430-0650 BLISTER PACK in 1 CARTON (0904-0430-06) / 1 TABLET, COATED in 1 BLISTER PACKEA
30904-0430-6110 BLISTER PACK in 1 CARTON (0904-0430-61) / 10 TABLET, COATED in 1 BLISTER PACKEA
40904-0430-9520 TABLET, COATED in 1 BOTTLE (0904-0430-95)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0904-0430The 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 NAMEDoxycyclineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE8/3/2004This 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 NUMBERANDA065095This 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 NAMEMajor PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC0904-0430The 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 DATE7/2/2003This 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 NUMBERANDA065095This 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 NAMEMajor PharmaceuticalsName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 7/4/2025

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