morphine sulfate

Generic: morphine sulfate

Labeler: lupin pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

morphine sulfate 200 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-544
Product ID 43386-544_d4efe614-fe99-4cc7-b3ba-87c4e010efbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203602
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2015-12-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386544
Hyphenated Format 43386-544

Supplemental Identifiers

RxCUI
891874 891881 891888 891893 892646
UPC
0343386542017 0343386543014 0343386540013 0343386541010
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 ANDA203602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-544-01)
source: ndc

Packages (1)

43386-544-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-544-01)

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": "d4efe614-fe99-4cc7-b3ba-87c4e010efbd", "openfda": {"upc": ["0343386542017", "0343386543014", "0343386540013", "0343386541010"], "unii": ["X3P646A2J0"], "rxcui": ["891874", "891881", "891888", "891893", "892646"], "spl_set_id": ["d360a33f-6323-4b10-9e81-07e2813c2dbd"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-544-01)", "package_ndc": "43386-544-01", "marketing_start_date": "20151216"}], "brand_name": "Morphine Sulfate", "product_id": "43386-544_d4efe614-fe99-4cc7-b3ba-87c4e010efbd", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "43386-544", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "200 mg/1"}], "application_number": "ANDA203602", "marketing_category": "ANDA", "marketing_start_date": "20151216", "listing_expiration_date": "20261231"}