10544-072 NDC - CYCLOBENZAPRINE HYDROCHLORIDE ()

Drug Information

  • Product NDC: 10544-072
  • Proprietary Name: Cyclobenzaprine Hydrochloride
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Blenheim Pharmacal, Inc.
Product Type:
FDA Application Number: ANDA071611
Marketing Category: ANDA
Start Marketing Date:3/30/2012

Package Information

No. Package Code Package Description Billing Unit
110544-072-00100 TABLET, FILM COATED in 1 BOTTLE (10544-072-00)
210544-072-022 TABLET, FILM COATED in 1 BOTTLE (10544-072-02)EA
310544-072-099 TABLET, FILM COATED in 1 BOTTLE (10544-072-09)
410544-072-1010 TABLET, FILM COATED in 1 BOTTLE (10544-072-10)EA
510544-072-1414 TABLET, FILM COATED in 1 BOTTLE (10544-072-14)EA
610544-072-1515 TABLET, FILM COATED in 1 BOTTLE (10544-072-15)EA
710544-072-2020 TABLET, FILM COATED in 1 BOTTLE (10544-072-20)EA
810544-072-2121 TABLET, FILM COATED in 1 BOTTLE (10544-072-21)EA
910544-072-3030 TABLET, FILM COATED in 1 BOTTLE (10544-072-30)EA
1010544-072-4545 TABLET, FILM COATED in 1 BOTTLE (10544-072-45)EA
1110544-072-6060 TABLET, FILM COATED in 1 BOTTLE (10544-072-60)EA
1210544-072-8484 TABLET, FILM COATED in 1 BOTTLE (10544-072-84)EA
1310544-072-9090 TABLET, FILM COATED in 1 BOTTLE (10544-072-90)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC10544-072The 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 NAMECyclobenzaprine HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/30/2012This 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 NUMBERANDA071611This 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 NAMEBlenheim Pharmacal, Inc.Name 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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