tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

tramadol hydrochloride 300 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-699
Product ID 68180-699_89cbc1ac-6681-42a9-b52a-0094f9b158a8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200503
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2014-08-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180699
Hyphenated Format 68180-699

Supplemental Identifiers

RxCUI
833709 833711 833713
UPC
0368180699064 0368180697060
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 ANDA200503 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-699-06)
source: ndc

Packages (1)

68180-699-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-699-06)

Ingredients (1)

tramadol hydrochloride (300 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": "89cbc1ac-6681-42a9-b52a-0094f9b158a8", "openfda": {"upc": ["0368180699064", "0368180697060"], "unii": ["9N7R477WCK"], "rxcui": ["833709", "833711", "833713"], "spl_set_id": ["46bb9ae6-3ee8-463c-badb-c7a45a89b84b"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-699-06)", "package_ndc": "68180-699-06", "marketing_start_date": "20140819"}], "brand_name": "TRAMADOL HYDROCHLORIDE", "product_id": "68180-699_89cbc1ac-6681-42a9-b52a-0094f9b158a8", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68180-699", "dea_schedule": "CIV", "generic_name": "TRAMADOL HYDROCHLORIDE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRAMADOL HYDROCHLORIDE", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA200503", "marketing_category": "ANDA", "marketing_start_date": "20140819", "listing_expiration_date": "20271231"}