morphine sulfate

Generic: morphine sulfate

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

morphine sulfate 10 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0904
Product ID 0121-0904_3652d47b-cb6f-455b-9ed3-1726b44cd105
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022195
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-03-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210904
Hyphenated Format 0121-0904

Supplemental Identifiers

RxCUI
892589
UNII
X3P646A2J0

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 NDA022195 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 3 TRAY in 1 CASE (0121-0904-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0904-05)
source: ndc

Packages (1)

0121-0904-94 3 TRAY in 1 CASE (0121-0904-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0904-05)

Ingredients (1)

morphine sulfate (10 mg/5mL)

Linked Drug Pages (1)

Morphine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3652d47b-cb6f-455b-9ed3-1726b44cd105", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["892589"], "spl_set_id": ["6e32b869-31c7-48c1-98ae-b21bd28151d7"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (0121-0904-94)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0904-05)", "package_ndc": "0121-0904-94", "marketing_start_date": "20201009"}], "brand_name": "Morphine Sulfate", "product_id": "0121-0904_3652d47b-cb6f-455b-9ed3-1726b44cd105", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0121-0904", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "10 mg/5mL"}], "application_number": "NDA022195", "marketing_category": "NDA", "marketing_start_date": "20170317", "listing_expiration_date": "20261231"}