NDC 68258-2003

TRAMADOL HYDROCHLORIDE

Tramadol Hydrochloride

TRAMADOL HYDROCHLORIDE is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Tramadol Hydrochloride.

Product ID68258-2003_c8366081-d57b-4c2e-8000-d4c607d6029f
NDC68258-2003
Product TypeHuman Prescription Drug
Proprietary NameTRAMADOL HYDROCHLORIDE
Generic NameTramadol Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-11-13
Marketing CategoryANDA / ANDA
Application NumberANDA078783
Labeler NameDispensing Solutions, Inc.
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength100 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68258-2003-3

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68258-2003-3)
Marketing Start Date2009-11-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68258-2003-3 [68258200303]

TRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078783
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-13
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE100 mg/1

OpenFDA Data

SPL SET ID:f2bd24a1-01cd-461b-a330-0456a0e5ee58
Manufacturer
UNII

Pharmacological Class

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

NDC Crossover Matching brand name "TRAMADOL HYDROCHLORIDE" or generic name "Tramadol Hydrochloride"

NDCBrand NameGeneric Name
0093-0058Tramadol HydrochlorideTramadol Hydrochloride
0378-4151Tramadol Hydrochloridetramadol hydrochloride
0378-4152Tramadol Hydrochloridetramadol hydrochloride
0378-4153Tramadol Hydrochloridetramadol hydrochloride
0378-4154Tramadol Hydrochloridetramadol hydrochloride
0615-7810Tramadol Hydrochloridetramadol hydrochloride
0615-8005Tramadol HydrochlorideTramadol Hydrochloride
0904-6365TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
0904-7179tramadol hydrochloridetramadol hydrochloride
10147-0901TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
10147-0902TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
10147-0903TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
10370-221Tramadol Hydrochloridetramadol hydrochloride
10370-222Tramadol HydrochlorideTramadol Hydrochloride
10370-223Tramadol HydrochlorideTramadol Hydrochloride
10544-009Tramadol HydrochlorideTramadol Hydrochloride
10544-531Tramadol HydrochlorideTramadol Hydrochloride
12634-786TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68071-3280TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68071-1978Tramadol HydrochlorideTramadol Hydrochloride
68071-3321TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68071-4119Tramadol HydrochlorideTramadol Hydrochloride
68071-4165TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68071-4154TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68071-4070TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68071-4282tramadol hydrochloridetramadol hydrochloride
68084-808Tramadol HydrochlorideTramadol Hydrochloride
68071-4802tramadol hydrochloridetramadol hydrochloride
68094-017Tramadol HydrochlorideTramadol Hydrochloride
68180-698TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68180-699TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68180-697TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68258-2003TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68382-319TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68387-900Tramadol HydrochlorideTramadol Hydrochloride
68788-7321tramadol hydrochloridetramadol hydrochloride
68788-9199Tramadol HydrochlorideTramadol Hydrochloride
68788-6929TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68788-8921TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68788-7284Tramadol HydrochlorideTramadol Hydrochloride
68788-7373TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68788-8920Tramadol HydrochlorideTramadol Hydrochloride
68788-9232TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
68788-9237TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE
69150-020Tramadol HydrochlorideTramadol Hydrochloride
69420-5150Tramadol HydrochlorideTramadol Hydrochloride
69467-1001Tramadol HydrochlorideTramadol Hydrochloride
69543-136Tramadol HydrochlorideTramadol Hydrochloride
69677-316Tramadol HydrochlorideTramadol Hydrochloride
70518-0054Tramadol HydrochlorideTramadol Hydrochloride

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