morphine sulfate extended release

Generic: morphine sulfate

Labeler: rhodes pharmaceuticals l. p.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 100 mg/1

Manufacturer
Rhodes Pharmaceuticals L. P.

Identifiers & Regulatory

Product NDC 42858-804
Product ID 42858-804_9af2bef8-f859-40eb-a60e-65474efe2f21
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074769
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 42858804
Hyphenated Format 42858-804

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 ANDA074769 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-804-01)
source: ndc

Packages (1)

42858-804-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-804-01)

Ingredients (1)

morphine sulfate (100 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 (42858-804-01)", "package_ndc": "42858-804-01", "marketing_start_date": "20110114"}], "brand_name": "Morphine Sulfate Extended Release", "product_id": "42858-804_9af2bef8-f859-40eb-a60e-65474efe2f21", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "42858-804", "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": "100 mg/1"}], "application_number": "ANDA074769", "marketing_category": "ANDA", "marketing_start_date": "20110114", "listing_expiration_date": "20271231"}