71335-0344 NDC - BACLOFEN ()

Drug Information

  • Product NDC: 71335-0344
  • Proprietary Name: Baclofen
  • Non Proprietary Name:
  • Active Ingredient(s): 10 mg/1 BACLOFEN
  • Administration Route(s):
  • Dosage Form(s):
  • Pharmacy Class(es): GABA A Agonists [MoA]; GABA B Agonists [MoA]; gamma-Aminobutyric Acid-ergic Agonist [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Bryant Ranch Prepack
Product Type:
FDA Application Number: ANDA078220
Marketing Category: ANDA
Start Marketing Date:7/1/2007
End Marketing Date:1/21/2022

Package Information

No. Package Code Package Description Billing Unit
171335-0344-0112 TABLET in 1 BOTTLE, PLASTIC (71335-0344-0)EA
271335-0344-0112 TABLET in 1 BOTTLE (71335-0344-0)EA
371335-0344-130 TABLET in 1 BOTTLE, PLASTIC (71335-0344-1)EA
471335-0344-130 TABLET in 1 BOTTLE (71335-0344-1)EA
571335-0344-2120 TABLET in 1 BOTTLE, PLASTIC (71335-0344-2)EA
671335-0344-2120 TABLET in 1 BOTTLE (71335-0344-2)EA
771335-0344-320 TABLET in 1 BOTTLE, PLASTIC (71335-0344-3)EA
871335-0344-320 TABLET in 1 BOTTLE (71335-0344-3)EA
971335-0344-460 TABLET in 1 BOTTLE, PLASTIC (71335-0344-4)EA
1071335-0344-460 TABLET in 1 BOTTLE (71335-0344-4)EA
1171335-0344-5100 TABLET in 1 BOTTLE, PLASTIC (71335-0344-5)EA
1271335-0344-5100 TABLET in 1 BOTTLE (71335-0344-5)EA
1371335-0344-656 TABLET in 1 BOTTLE, PLASTIC (71335-0344-6)EA
1471335-0344-656 TABLET in 1 BOTTLE (71335-0344-6)EA
1571335-0344-790 TABLET in 1 BOTTLE, PLASTIC (71335-0344-7)EA
1671335-0344-790 TABLET in 1 BOTTLE (71335-0344-7)EA
1771335-0344-8140 TABLET in 1 BOTTLE, PLASTIC (71335-0344-8)EA
1871335-0344-8140 TABLET in 1 BOTTLE (71335-0344-8)EA
1971335-0344-984 TABLET in 1 BOTTLE, PLASTIC (71335-0344-9)EA
2071335-0344-984 TABLET in 1 BOTTLE (71335-0344-9)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC71335-0344The 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 NAMEBaclofenThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE7/1/2007This 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 NUMBERANDA078220This 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 NAMEBryant Ranch PrepackName of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC71335-0344The 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 NAMEBaclofenThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE7/1/2007This 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 NUMBERANDA078220This 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 NAMEBryant Ranch PrepackName 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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