morphine sulfate extended release

Generic: morphine sulfate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

morphine sulfate 200 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8505
Product ID 63629-8505_e838f369-2033-4511-be58-02689fbba167
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074769
DEA Schedule cii
Listing Expiration 2026-12-31
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 636298505
Hyphenated Format 63629-8505

Supplemental Identifiers

RxCUI
892646
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
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-8505-1)
source: ndc

Packages (1)

63629-8505-1 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-8505-1)

Ingredients (1)

morphine sulfate (200 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": "e838f369-2033-4511-be58-02689fbba167", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["892646"], "spl_set_id": ["2dd52157-3121-41ed-abc2-99b269531e56"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-8505-1)", "package_ndc": "63629-8505-1", "marketing_start_date": "20240404"}], "brand_name": "Morphine Sulfate Extended Release", "product_id": "63629-8505_e838f369-2033-4511-be58-02689fbba167", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63629-8505", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA074769", "marketing_category": "ANDA", "marketing_start_date": "20110114", "listing_expiration_date": "20261231"}