tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler direct rx
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 200 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 61919-893
Product ID 61919-893_24ac4469-6ec1-7d80-e063-6394a90aacf5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201384
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-01-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919893
Hyphenated Format 61919-893

Supplemental Identifiers

RxCUI
833709 833711 835603
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 ANDA201384 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-893-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-893-60)
source: ndc

Packages (2)

61919-893-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-893-30) 61919-893-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-893-60)

Ingredients (1)

tramadol hydrochloride (200 mg/1)

Linked Drug Pages (1)

TRAMADOL HCL ER, TRAMADOL HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "24ac4469-6ec1-7d80-e063-6394a90aacf5", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["833709", "833711", "835603"], "spl_set_id": ["5285f056-c32c-4e7a-bec6-3a726aa23d5a"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-893-30)", "package_ndc": "61919-893-30", "marketing_start_date": "20150626"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-893-60)", "package_ndc": "61919-893-60", "marketing_start_date": "20140101"}], "brand_name": "TRAMADOL HYDROCHLORIDE", "product_id": "61919-893_24ac4469-6ec1-7d80-e063-6394a90aacf5", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "61919-893", "dea_schedule": "CIV", "generic_name": "TRAMADOL HYDROCHLORIDE", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRAMADOL HYDROCHLORIDE", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA201384", "marketing_category": "ANDA", "marketing_start_date": "20140101", "listing_expiration_date": "20261231"}