morphine sulfate (0406-8003)

Drug Facts

Product Profile

Brand Name morphine sulfate

Generic Name morphine sulfate

Labeler specgx llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

morphine sulfate 20 mg/mL

Manufacturer

SpecGx LLC

Identifiers & Regulatory

Product NDC 0406-8003

Product ID 0406-8003_852596c9-601f-477c-9966-580f728d9e54

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202348

DEA Schedule cii

Listing Expiration 2026-12-31

Marketing Start 2011-07-15

Pharmacologic Class

Classes

full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04068003

Hyphenated Format 0406-8003

Supplemental Identifiers

RxCUI

892625

UPC

0304068003240

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 ANDA202348 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/mL

source: ndc

Packaging

6 CARTON in 1 CASE (0406-8003-12) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC
6 CARTON in 1 CASE (0406-8003-15) / 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC
6 CARTON in 1 CASE (0406-8003-24) / 1 BOTTLE, PLASTIC in 1 CARTON / 240 mL in 1 BOTTLE, PLASTIC
6 CARTON in 1 CASE (0406-8003-30) / 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (4)

0406-8003-12 6 CARTON in 1 CASE (0406-8003-12) / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC 0406-8003-15 6 CARTON in 1 CASE (0406-8003-15) / 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC 0406-8003-24 6 CARTON in 1 CASE (0406-8003-24) / 1 BOTTLE, PLASTIC in 1 CARTON / 240 mL in 1 BOTTLE, PLASTIC 0406-8003-30 6 CARTON in 1 CASE (0406-8003-30) / 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

morphine sulfate (20 mg/mL)

Linked Drug Pages (1)

Morphine Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "852596c9-601f-477c-9966-580f728d9e54", "openfda": {"upc": ["0304068003240"], "unii": ["X3P646A2J0"], "rxcui": ["892625"], "spl_set_id": ["242c2512-1d49-486b-a9c3-6905f667799e"], "manufacturer_name": ["SpecGx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 CARTON in 1 CASE (0406-8003-12)  / 1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0406-8003-12", "marketing_start_date": "20110715"}, {"sample": false, "description": "6 CARTON in 1 CASE (0406-8003-15)  / 1 BOTTLE, PLASTIC in 1 CARTON / 15 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0406-8003-15", "marketing_start_date": "20110715"}, {"sample": false, "description": "6 CARTON in 1 CASE (0406-8003-24)  / 1 BOTTLE, PLASTIC in 1 CARTON / 240 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0406-8003-24", "marketing_start_date": "20110715"}, {"sample": false, "description": "6 CARTON in 1 CASE (0406-8003-30)  / 1 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0406-8003-30", "marketing_start_date": "20110715"}], "brand_name": "Morphine Sulfate", "product_id": "0406-8003_852596c9-601f-477c-9966-580f728d9e54", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0406-8003", "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": "20 mg/mL"}], "application_number": "ANDA202348", "marketing_category": "ANDA", "marketing_start_date": "20110715", "listing_expiration_date": "20261231"}