NDC 60429-583

Tramadol Hydrochloride Extended-Release

Tramadol Hydrochloride Extended-release Tablets

Tramadol Hydrochloride Extended-Release is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Golden State Medical Supply, Inc.. The primary component is Tramadol Hydrochloride.

Product ID60429-583_7acc981e-0bff-1a70-e053-2991aa0a648b
NDC60429-583
Product TypeHuman Prescription Drug
Proprietary NameTramadol Hydrochloride Extended-Release
Generic NameTramadol Hydrochloride Extended-release Tablets
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-10-20
Marketing CategoryANDA / ANDA
Application NumberANDA200491
Labeler NameGolden State Medical Supply, Inc.
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 60429-583-30

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (60429-583-30)
Marketing Start Date2016-10-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60429-583-30 [60429058330]

Tramadol Hydrochloride Extended-Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA200491
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-20

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:7388d49b-d1b2-4cbb-9bde-50dbbdd78889
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1946529
  • 1946525
  • 1946527
  • Pharmacological Class

    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    NDC Crossover Matching brand name "Tramadol Hydrochloride Extended-Release" or generic name "Tramadol Hydrochloride Extended-release Tablets"

    NDCBrand NameGeneric Name
    13811-691Tramadol Hydrochloride Extended-ReleaseTramadol Hydrochloride Extended-Release
    13811-690Tramadol Hydrochloride Extended-ReleaseTramadol Hydrochloride Extended-Release
    13811-689Tramadol Hydrochloride Extended-ReleaseTramadol Hydrochloride Extended-Release
    60429-583Tramadol Hydrochloridetramadol hydrochloride extended-release tablets
    60429-584Tramadol HydrochlorideTramadol Hydrochloride Extended-Release Tablets
    60429-585Tramadol HydrochlorideTramadol Hydrochloride Extended-Release Tablets

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.