morphine sulfate

Generic: morphine sulfate

Labeler: specgx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler specgx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

morphine sulfate 15 mg/1

Manufacturer
SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-5118
Product ID 0406-5118_675ff1e4-12b4-4141-8811-ef442950ea23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215194
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04065118
Hyphenated Format 0406-5118

Supplemental Identifiers

RxCUI
892582 892672
UPC
0304065119012 0304065118015
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 ANDA215194 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0406-5118-01)
  • 10 BLISTER PACK in 1 CARTON (0406-5118-62) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

0406-5118-01 100 TABLET in 1 BOTTLE (0406-5118-01) 0406-5118-62 10 BLISTER PACK in 1 CARTON (0406-5118-62) / 10 TABLET in 1 BLISTER PACK

Ingredients (1)

morphine sulfate (15 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": "675ff1e4-12b4-4141-8811-ef442950ea23", "openfda": {"upc": ["0304065119012", "0304065118015"], "unii": ["X3P646A2J0"], "rxcui": ["892582", "892672"], "spl_set_id": ["8b69f67f-30b3-4982-953e-5a4b87ec6ac6"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0406-5118-01)", "package_ndc": "0406-5118-01", "marketing_start_date": "20230901"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0406-5118-62)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "0406-5118-62", "marketing_start_date": "20230901"}], "brand_name": "Morphine Sulfate", "product_id": "0406-5118_675ff1e4-12b4-4141-8811-ef442950ea23", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-5118", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "SpecGx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "15 mg/1"}], "application_number": "ANDA215194", "marketing_category": "ANDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}