tramadol hydrochloride (68180-385)

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 68180-385

Product ID 68180-385_e674f8e1-d70a-4e39-b2c3-6b7ad77e3796

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA200503

DEA Schedule civ

Listing Expiration 2026-12-31

Marketing Start 2011-09-26

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180385

Hyphenated Format 68180-385

Supplemental Identifiers

RxCUI

833709 833711 833713

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

HOW SUPPLIED Tramadol Hydrochloride Extended-Release Tablets are supplied in the following package and dose strength forms: 100 mg: White to off-white circular, biconvex, beveled edge coated tablets imprinted with 'L010'on one side and plain on the other side. Bottles of 30 tablets : NDC 68180-383-06 Bottles of 100 tablets : NDC 68180-383-01 Bottles of 500 tablets : NDC 68180-383-02 200 mg: White to off-white circular, biconvex, beveled edge coated tablets imprinted with 'L011'on one side and plain on the other side. Bottles of 30 tablets : NDC 68180-384-06 Bottles of 100 tablets : NDC 68180-384-01 Bottles of 500 tablets : NDC 68180-384-02 300 mg: White to off-white circular, biconvex, beveled edge coated tablets imprinted with 'L012'on one side and plain on the other side. Bottles of 30 tablets : NDC 68180-385-06 Bottles of 100 tablets : NDC 68180-385-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA January 2011 ID#224144
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 100 mg NDC 68180-383-06 30 TABLETS TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 200 mg NDC 68180-384-06 30 TABLETS TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS Rx Only 300 mg NDC 68180-385-06 30 TABLETS 100mg-30tabs 200mg-30tabs 300mg-30tabs

source: label

Packages (0)

No package records.

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": "e674f8e1-d70a-4e39-b2c3-6b7ad77e3796", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["833709", "833711", "833713"], "spl_set_id": ["3e0ccb95-3e8e-477c-b4d2-6060ee05f930"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Tramadol Hydrochloride", "product_id": "68180-385_e674f8e1-d70a-4e39-b2c3-6b7ad77e3796", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68180-385", "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": "20110926", "listing_expiration_date": "20261231"}