morphine sulfate

Generic: morphine sulfate

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

morphine sulfate 80 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1281
Product ID 0115-1281_b2330bfc-8b32-421e-ade5-2076ee23cebb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200411
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2016-04-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151281
Hyphenated Format 0115-1281

Supplemental Identifiers

RxCUI
892345 892352 892554 892596 894801 894814 1303736
UPC
0301151281011 0301151280014
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 ANDA200411 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-01)
  • 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-03)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-08)
source: ndc

Packages (3)

0115-1281-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-01) 0115-1281-03 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-03) 0115-1281-08 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-08)

Ingredients (1)

morphine sulfate (80 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": "b2330bfc-8b32-421e-ade5-2076ee23cebb", "openfda": {"upc": ["0301151281011", "0301151280014"], "unii": ["X3P646A2J0"], "rxcui": ["892345", "892352", "892554", "892596", "894801", "894814", "1303736"], "spl_set_id": ["f7e9a4b3-a2ee-4f0a-becd-6ef90867332b"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-01)", "package_ndc": "0115-1281-01", "marketing_start_date": "20160412"}, {"sample": false, "description": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-03)", "package_ndc": "0115-1281-03", "marketing_start_date": "20160412"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1281-08)", "package_ndc": "0115-1281-08", "marketing_start_date": "20160412"}], "brand_name": "Morphine Sulfate", "product_id": "0115-1281_b2330bfc-8b32-421e-ade5-2076ee23cebb", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0115-1281", "dea_schedule": "CII", "generic_name": "MORPHINE SULFATE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "80 mg/1"}], "application_number": "ANDA200411", "marketing_category": "ANDA", "marketing_start_date": "20160412", "listing_expiration_date": "20271231"}