tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 100 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-859
Product ID 47335-859_a994e116-d201-47f9-baaf-dd76a84eba7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201384
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2011-12-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335859
Hyphenated Format 47335-859

Supplemental Identifiers

RxCUI
833709 833711 833713
UPC
0347335861839 0347335860832 0347335859836
UNII
9N7R477WCK

Packaging Origin

Original Packager
true

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
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-08)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-18)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-83)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-88)
source: ndc

Packages (4)

47335-859-08 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-08) 47335-859-18 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-18) 47335-859-83 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-83) 47335-859-88 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-88)

Ingredients (1)

tramadol hydrochloride (100 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": "a994e116-d201-47f9-baaf-dd76a84eba7e", "openfda": {"upc": ["0347335861839", "0347335860832", "0347335859836"], "unii": ["9N7R477WCK"], "rxcui": ["833709", "833711", "833713"], "spl_set_id": ["004de5a4-80f8-4040-a6ea-be5e99352a36"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-08)", "package_ndc": "47335-859-08", "marketing_start_date": "20111212"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-18)", "package_ndc": "47335-859-18", "marketing_start_date": "20111212"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-83)", "package_ndc": "47335-859-83", "marketing_start_date": "20111212"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-859-88)", "package_ndc": "47335-859-88", "marketing_start_date": "20111212"}], "brand_name": "TRAMADOL HYDROCHLORIDE", "product_id": "47335-859_a994e116-d201-47f9-baaf-dd76a84eba7e", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "47335-859", "dea_schedule": "CIV", "generic_name": "TRAMADOL HYDROCHLORIDE", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRAMADOL HYDROCHLORIDE", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA201384", "marketing_category": "ANDA", "marketing_start_date": "20111212", "listing_expiration_date": "20261231"}