morphine sulfate

Generic: morphine sulfate

Labeler: nortec development associates, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler nortec development associates, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

morphine sulfate 20 mg/1

Manufacturer
Nortec Development Associates, Inc.

Identifiers & Regulatory

Product NDC 42689-005
Product ID 42689-005_863bb977-9d7b-4258-a6ff-3ed2eeefeb81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203158
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2009-04-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42689005
Hyphenated Format 42689-005

Supplemental Identifiers

RxCUI
892345 892352 892554 892596 894801 894814
UPC
0342689009012 0342689008015 0342689007018 0342689010018
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 ANDA203158 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-005-01)
source: ndc

Packages (1)

42689-005-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-005-01)

Ingredients (1)

morphine sulfate (20 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": "863bb977-9d7b-4258-a6ff-3ed2eeefeb81", "openfda": {"upc": ["0342689009012", "0342689008015", "0342689007018", "0342689010018"], "unii": ["X3P646A2J0"], "rxcui": ["892345", "892352", "892554", "892596", "894801", "894814"], "spl_set_id": ["9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4"], "manufacturer_name": ["Nortec Development Associates, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-005-01)", "package_ndc": "42689-005-01", "marketing_start_date": "20090407"}], "brand_name": "Morphine Sulfate", "product_id": "42689-005_863bb977-9d7b-4258-a6ff-3ed2eeefeb81", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "42689-005", "dea_schedule": "CII", "generic_name": "morphine sulfate", "labeler_name": "Nortec Development Associates, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "20 mg/1"}], "application_number": "ANDA203158", "marketing_category": "ANDA", "marketing_start_date": "20090407", "listing_expiration_date": "20261231"}