NDC 52605-010

Tramadol Hydrochloride

Tramadol Hydrochloride

Tramadol Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Polygen Pharmaceuticals Inc.. The primary component is Tramadol Hydrochloride.

Product ID52605-010_6d58111e-f9d8-403c-af24-139c9cab07e9
NDC52605-010
Product TypeHuman Prescription Drug
Proprietary NameTramadol Hydrochloride
Generic NameTramadol Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-01-13
Marketing CategoryANDA / ANDA
Application NumberANDA206706
Labeler NamePOLYGEN PHARMACEUTICALS INC.
Substance NameTRAMADOL HYDROCHLORIDE
Active Ingredient Strength50 mg/1
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52605-010-01

100 TABLET, FILM COATED in 1 BOTTLE (52605-010-01)
Marketing Start Date2015-01-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52605-010-01 [52605001001]

Tramadol Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-06-01

NDC 52605-010-10 [52605001010]

Tramadol Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206706
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-06-01

Drug Details

Active Ingredients

IngredientStrength
TRAMADOL HYDROCHLORIDE50 mg/1

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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