morphine sulfate extended release (42858-801)

Drug Facts

Product Profile

Brand Name morphine sulfate extended release

Generic Name morphine sulfate

Labeler rhodes pharmaceuticals l. p.

Dosage Form TABLET, FILM COATED, EXTENDED RELEASE

Routes

ORAL

Active Ingredients

morphine sulfate 15 mg/1

Manufacturer

Rhodes Pharmaceuticals L. P.

Identifiers & Regulatory

Product NDC 42858-801

Product ID 42858-801_9af2bef8-f859-40eb-a60e-65474efe2f21

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA074862

DEA Schedule cii

Listing Expiration 2027-12-31

Marketing Start 2011-01-14

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42858801

Hyphenated Format 42858-801

Supplemental Identifiers

RxCUI

891874 891881 891888 891893 892646

UPC

0342858803014 0342858801010 0342858802017 0342858805018

UNII

X3P646A2J0

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 morphine sulfate extended release (source: ndc)

Generic Name morphine sulfate (source: ndc)

Application Number ANDA074862 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

15 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-801-01)

source: ndc

Packages (1)

42858-801-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-801-01)

Ingredients (1)

morphine sulfate (15 mg/1)

Linked Drug Pages (1)

Morphine Sulfate Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "9af2bef8-f859-40eb-a60e-65474efe2f21", "openfda": {"upc": ["0342858803014", "0342858801010", "0342858802017", "0342858805018"], "unii": ["X3P646A2J0"], "rxcui": ["891874", "891881", "891888", "891893", "892646"], "spl_set_id": ["19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804"], "manufacturer_name": ["Rhodes Pharmaceuticals L. P."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-801-01)", "package_ndc": "42858-801-01", "marketing_start_date": "20110114"}], "brand_name": "Morphine Sulfate Extended Release", "product_id": "42858-801_9af2bef8-f859-40eb-a60e-65474efe2f21", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "42858-801", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "Rhodes Pharmaceuticals L. P.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "15 mg/1"}], "application_number": "ANDA074862", "marketing_category": "ANDA", "marketing_start_date": "20110114", "listing_expiration_date": "20271231"}