tramadol hcl er

Generic: tramadol hcl

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

Drug Facts

Product Profile

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

tramadol hydrochloride 100 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 61919-818
Product ID 61919-818_24ac4469-6ec1-7d80-e063-6394a90aacf5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200503
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2019-05-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919818
Hyphenated Format 61919-818

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

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-60)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-90)
source: ndc

Packages (3)

61919-818-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-30) 61919-818-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-60) 61919-818-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-90)

Ingredients (1)

tramadol hydrochloride (100 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 (61919-818-30)", "package_ndc": "61919-818-30", "marketing_start_date": "20190503"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-60)", "package_ndc": "61919-818-60", "marketing_start_date": "20190503"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-90)", "package_ndc": "61919-818-90", "marketing_start_date": "20190503"}], "brand_name": "TRAMADOL HCL ER", "product_id": "61919-818_24ac4469-6ec1-7d80-e063-6394a90aacf5", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "61919-818", "dea_schedule": "CIV", "generic_name": "TRAMADOL HCL", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRAMADOL HCL", "brand_name_suffix": "ER", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA200503", "marketing_category": "ANDA", "marketing_start_date": "20190503", "listing_expiration_date": "20261231"}