tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: redpharm drug inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler redpharm drug inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
RedPharm Drug Inc

Identifiers & Regulatory

Product NDC 67296-1834
Product ID 67296-1834_4387f592-853f-01ea-e063-6394a90a6a4f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208708
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2021-04-22

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 672961834
Hyphenated Format 67296-1834

Supplemental Identifiers

RxCUI
835603
UPC
0372888080017 0372888080000 0372888008011 0372888008004 0372888080055 0372888008059
UNII
9N7R477WCK

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tramadol hydrochloride (source: ndc)
Generic Name tramadol hydrochloride (source: ndc)
Application Number ANDA208708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 TABLET, COATED in 1 BOTTLE (67296-1834-1)
  • 20 TABLET, COATED in 1 BOTTLE (67296-1834-2)
  • 30 TABLET, COATED in 1 BOTTLE (67296-1834-3)
  • 40 TABLET, COATED in 1 BOTTLE (67296-1834-4)
  • 6 TABLET, COATED in 1 BOTTLE (67296-1834-6)
  • 15 TABLET, COATED in 1 BOTTLE (67296-1834-7)
source: ndc

Packages (6)

67296-1834-1 10 TABLET, COATED in 1 BOTTLE (67296-1834-1) 67296-1834-2 20 TABLET, COATED in 1 BOTTLE (67296-1834-2) 67296-1834-3 30 TABLET, COATED in 1 BOTTLE (67296-1834-3) 67296-1834-4 40 TABLET, COATED in 1 BOTTLE (67296-1834-4) 67296-1834-6 6 TABLET, COATED in 1 BOTTLE (67296-1834-6) 67296-1834-7 15 TABLET, COATED in 1 BOTTLE (67296-1834-7)

Ingredients (1)

tramadol hydrochloride (50 mg/1)

Linked Drug Pages (1)

Tramadol Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4387f592-853f-01ea-e063-6394a90a6a4f", "openfda": {"upc": ["0372888080017", "0372888080000", "0372888008011", "0372888008004", "0372888080055", "0372888008059"], "unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["f4c148f3-845a-61e3-e053-2a95a90a326e"], "manufacturer_name": ["RedPharm Drug Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, COATED in 1 BOTTLE (67296-1834-1)", "package_ndc": "67296-1834-1", "marketing_start_date": "20210422"}, {"sample": false, "description": "20 TABLET, COATED in 1 BOTTLE (67296-1834-2)", "package_ndc": "67296-1834-2", "marketing_start_date": "20210422"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (67296-1834-3)", "package_ndc": "67296-1834-3", "marketing_start_date": "20210422"}, {"sample": false, "description": "40 TABLET, COATED in 1 BOTTLE (67296-1834-4)", "package_ndc": "67296-1834-4", "marketing_start_date": "20210422"}, {"sample": false, "description": "6 TABLET, COATED in 1 BOTTLE (67296-1834-6)", "package_ndc": "67296-1834-6", "marketing_start_date": "20210422"}, {"sample": false, "description": "15 TABLET, COATED in 1 BOTTLE (67296-1834-7)", "package_ndc": "67296-1834-7", "marketing_start_date": "20210422"}], "brand_name": "Tramadol Hydrochloride", "product_id": "67296-1834_4387f592-853f-01ea-e063-6394a90a6a4f", "dosage_form": "TABLET, COATED", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "67296-1834", "dea_schedule": "CIV", "generic_name": "Tramadol Hydrochloride", "labeler_name": "RedPharm Drug Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol Hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA208708", "marketing_category": "ANDA", "marketing_start_date": "20210422", "listing_expiration_date": "20261231"}