tramadol hcl er

Generic: tramadol hcl er

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hcl er
Generic Name tramadol hcl er
Labeler direct_rx
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 300 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-521
Product ID 72189-521_2c4e6900-1d19-f1d7-e063-6394a90a16d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200503
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2023-11-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189521
Hyphenated Format 72189-521

Supplemental Identifiers

RxCUI
833713
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 hcl er (source: ndc)
Generic Name tramadol hcl er (source: ndc)
Application Number ANDA200503 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-521-30)
source: ndc

Packages (1)

72189-521-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-521-30)

Ingredients (1)

tramadol hydrochloride (300 mg/1)

Linked Drug Pages (1)

Tramadol HCL ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c4e6900-1d19-f1d7-e063-6394a90a16d5", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["833713"], "spl_set_id": ["09a7af47-423a-1e8b-e063-6394a90a99ef"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-521-30)", "package_ndc": "72189-521-30", "marketing_start_date": "20231108"}], "brand_name": "Tramadol HCL ER", "product_id": "72189-521_2c4e6900-1d19-f1d7-e063-6394a90a16d5", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "72189-521", "dea_schedule": "CIV", "generic_name": "Tramadol HCL ER", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tramadol HCL ER", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA200503", "marketing_category": "ANDA", "marketing_start_date": "20231108", "listing_expiration_date": "20261231"}