morphine sulfate er

Generic: morphine sulfate

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

Drug Facts

Product Profile

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

morphine sulfate 15 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-4483
Product ID 63629-4483_40226312-c4ea-4447-88da-c8d11816036b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074862
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 636294483
Hyphenated Format 63629-4483

Supplemental Identifiers

RxCUI
891881
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 er (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
  • 26 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-0)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-1)
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-2)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-3)
  • 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-4)
  • 40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-5)
  • 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-6)
  • 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-7)
  • 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-8)
  • 84 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-9)
source: ndc

Packages (10)

63629-4483-0 26 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-0) 63629-4483-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-1) 63629-4483-2 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-2) 63629-4483-3 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-3) 63629-4483-4 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-4) 63629-4483-5 40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-5) 63629-4483-6 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-6) 63629-4483-7 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-7) 63629-4483-8 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-8) 63629-4483-9 84 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-9)

Ingredients (1)

morphine sulfate (15 mg/1)

Linked Drug Pages (1)

Morphine Sulfate ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40226312-c4ea-4447-88da-c8d11816036b", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["891881"], "spl_set_id": ["872ceecb-1f14-7a43-7451-e4650a01fbd9"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "26 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-0)", "package_ndc": "63629-4483-0", "marketing_start_date": "20220103"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-1)", "package_ndc": "63629-4483-1", "marketing_start_date": "20110420"}, {"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-2)", "package_ndc": "63629-4483-2", "marketing_start_date": "20110414"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-3)", "package_ndc": "63629-4483-3", "marketing_start_date": "20110711"}, {"sample": false, "description": "120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-4)", "package_ndc": "63629-4483-4", "marketing_start_date": "20220103"}, {"sample": false, "description": "40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-5)", "package_ndc": "63629-4483-5", "marketing_start_date": "20220103"}, {"sample": false, "description": "14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-6)", "package_ndc": "63629-4483-6", "marketing_start_date": "20120813"}, {"sample": false, "description": "15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-7)", "package_ndc": "63629-4483-7", "marketing_start_date": "20140429"}, {"sample": false, "description": "20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-8)", "package_ndc": "63629-4483-8", "marketing_start_date": "20220103"}, {"sample": false, "description": "84 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-9)", "package_ndc": "63629-4483-9", "marketing_start_date": "20150415"}], "brand_name": "Morphine Sulfate ER", "product_id": "63629-4483_40226312-c4ea-4447-88da-c8d11816036b", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63629-4483", "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": "ER", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "15 mg/1"}], "application_number": "ANDA074862", "marketing_category": "ANDA", "marketing_start_date": "20110114", "listing_expiration_date": "20261231"}