NDC 80425-0108

Ultram

Tramadol Hcl 100mg

Ultram is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Advanced Rx Pharmacy Of Tennessee, Llc. The primary component is Tramadol Hydrochloride.

Product ID80425-0108_b4f9bc4f-9dcb-090f-e053-2a95a90a07d9
NDC80425-0108
Product TypeHuman Prescription Drug
Proprietary NameUltram
Generic NameTramadol Hcl 100mg
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-08-19
Marketing CategoryANDA / ANDA
Application NumberANDA200503
Labeler NameAdvanced Rx Pharmacy of Tennessee, LLC
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 80425-0108-2

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0108-2)
Marketing Start Date2014-08-19
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Ultram" or generic name "Tramadol Hcl 100mg"

NDCBrand NameGeneric Name
50458-659ULTRAMtramadol hydrochloride
51655-185UltramTRAMADOL HCL
80425-0057UltramTramadol HCl 50mg
80425-0058UltramTramadol HCl 50mg
80425-0108UltramTramadol HCl 100mg
80425-0141UltramTramadol 100mg
80425-0159UltramTramadol 50mg

Trademark Results [Ultram]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ULTRAM
ULTRAM
73811654 1583293 Live/Registered
JOHNSON & JOHNSON
1989-07-10

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