morphine sulfate

Generic: morphine sulfate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

morphine sulfate 200 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-453
Product ID 63304-453_39a0166a-c2ca-47bf-8654-85e0a431b9a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078761
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2012-05-11

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304453
Hyphenated Format 63304-453

Supplemental Identifiers

RxCUI
891874 891881 891888 891893 892646
UPC
0363304453010 0363304758016 0363304452013 0363304450019 0363304451016
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 (source: ndc)
Generic Name morphine sulfate (source: ndc)
Application Number ANDA078761 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-453-01)
  • 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-453-03)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-453-05)
source: ndc

Packages (3)

63304-453-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-453-01) 63304-453-03 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-453-03) 63304-453-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-453-05)

Ingredients (1)

morphine sulfate (200 mg/1)

Linked Drug Pages (1)

Morphine sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39a0166a-c2ca-47bf-8654-85e0a431b9a0", "openfda": {"upc": ["0363304453010", "0363304758016", "0363304452013", "0363304450019", "0363304451016"], "unii": ["X3P646A2J0"], "rxcui": ["891874", "891881", "891888", "891893", "892646"], "spl_set_id": ["736c9b80-682c-4cda-bf18-61b18de0bd39"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-453-01)", "package_ndc": "63304-453-01", "marketing_start_date": "20120511"}, {"sample": false, "description": "10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-453-03)", "package_ndc": "63304-453-03", "marketing_start_date": "20120511"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-453-05)", "package_ndc": "63304-453-05", "marketing_start_date": "20120511"}], "brand_name": "Morphine sulfate", "product_id": "63304-453_39a0166a-c2ca-47bf-8654-85e0a431b9a0", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "63304-453", "dea_schedule": "CII", "generic_name": "morphine sulfate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA078761", "marketing_category": "ANDA", "marketing_start_date": "20120511", "listing_expiration_date": "20261231"}