morphine sulfate

Generic: morphine sulfate

Labeler: winder laboratories llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate
Generic Name morphine sulfate
Labeler winder laboratories llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

morphine sulfate 100 mg/5mL

Manufacturer
Winder Laboratories LLC

Identifiers & Regulatory

Product NDC 75826-131
Product ID 75826-131_2b0eba4c-7f43-72ef-e063-6294a90afd7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211454
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75826131
Hyphenated Format 75826-131

Supplemental Identifiers

RxCUI
892589 892625 894780
UPC
0375826130058 0375826131154 0375826129052
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 ANDA211454 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, PLASTIC (75826-131-01)
  • 120 mL in 1 BOTTLE, PLASTIC (75826-131-04)
  • 15 mL in 1 BOTTLE, PLASTIC (75826-131-15)
source: ndc

Packages (3)

75826-131-01 30 mL in 1 BOTTLE, PLASTIC (75826-131-01) 75826-131-04 120 mL in 1 BOTTLE, PLASTIC (75826-131-04) 75826-131-15 15 mL in 1 BOTTLE, PLASTIC (75826-131-15)

Ingredients (1)

morphine sulfate (100 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": "2b0eba4c-7f43-72ef-e063-6294a90afd7e", "openfda": {"upc": ["0375826130058", "0375826131154", "0375826129052"], "unii": ["X3P646A2J0"], "rxcui": ["892589", "892625", "894780"], "spl_set_id": ["e9a7319a-bf1f-48db-a71e-6d4e6ead9555"], "manufacturer_name": ["Winder Laboratories LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, PLASTIC (75826-131-01)", "package_ndc": "75826-131-01", "marketing_start_date": "20220301"}, {"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (75826-131-04)", "package_ndc": "75826-131-04", "marketing_start_date": "20190515"}, {"sample": false, "description": "15 mL in 1 BOTTLE, PLASTIC (75826-131-15)", "package_ndc": "75826-131-15", "marketing_start_date": "20190515"}], "brand_name": "Morphine Sulfate", "product_id": "75826-131_2b0eba4c-7f43-72ef-e063-6294a90afd7e", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "75826-131", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "Winder Laboratories LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "100 mg/5mL"}], "application_number": "ANDA211454", "marketing_category": "ANDA", "marketing_start_date": "20190515", "listing_expiration_date": "20261231"}