morphine sulfate extended release

Generic: morphine sulfate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate extended release
Generic Name morphine sulfate
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

morphine sulfate 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6560
Product ID 0904-6560_225b222a-4968-42ab-95b0-4576bf995515
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 09046560
Hyphenated Format 0904-6560

Supplemental Identifiers

RxCUI
891874 891881 891888 891893
UNII
X3P646A2J0

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 BLISTER PACK in 1 CARTON (0904-6560-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6560-61 100 BLISTER PACK in 1 CARTON (0904-6560-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

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": "225b222a-4968-42ab-95b0-4576bf995515", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["891874", "891881", "891888", "891893"], "spl_set_id": ["dbb37dfd-0196-45f7-b9ca-393f56cf1d28"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6560-61)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-6560-61", "marketing_start_date": "20110114"}], "brand_name": "Morphine Sulfate Extended Release", "product_id": "0904-6560_225b222a-4968-42ab-95b0-4576bf995515", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0904-6560", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "Major Pharmaceuticals", "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"}