morphine sulfate

Generic: morphine sulfate

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler actavis pharma, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

morphine sulfate 45 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0228-3116
Product ID 0228-3116_ae4b4521-8f26-4b75-8823-1df3d9deb2b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079040
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2014-02-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02283116
Hyphenated Format 0228-3116

Supplemental Identifiers

RxCUI
892297 892342 892349 892355 894942 894970
UPC
0302283090113 0302283093114
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 ANDA079040 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 45 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3116-11)
source: ndc

Packages (1)

0228-3116-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3116-11)

Ingredients (1)

morphine sulfate (45 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": "ae4b4521-8f26-4b75-8823-1df3d9deb2b3", "openfda": {"upc": ["0302283090113", "0302283093114"], "unii": ["X3P646A2J0"], "rxcui": ["892297", "892342", "892349", "892355", "894942", "894970"], "spl_set_id": ["2da87bfa-11fd-43e3-8fef-d16ebeb15680"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3116-11)", "package_ndc": "0228-3116-11", "marketing_start_date": "20140204"}], "brand_name": "Morphine sulfate", "product_id": "0228-3116_ae4b4521-8f26-4b75-8823-1df3d9deb2b3", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0228-3116", "dea_schedule": "CII", "generic_name": "Morphine sulfate", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "45 mg/1"}], "application_number": "ANDA079040", "marketing_category": "ANDA", "marketing_start_date": "20140204", "listing_expiration_date": "20261231"}