duramorph

Generic: morphine sulfate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name duramorph
Generic Name morphine sulfate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
EPIDURAL INTRATHECAL INTRAVENOUS
Active Ingredients

morphine sulfate .5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6020
Product ID 0641-6020_aa74af85-7068-4254-9a79-c7f3792044a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018565
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 1984-09-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416020
Hyphenated Format 0641-6020

Supplemental Identifiers

RxCUI
892473 892489 1728783 1728800
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 duramorph (source: ndc)
Generic Name morphine sulfate (source: ndc)
Application Number NDA018565 (source: ndc)
Routes
EPIDURAL INTRATHECAL INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 CARTON (0641-6020-10) / 10 mL in 1 AMPULE (0641-6020-01)
source: ndc

Packages (1)

0641-6020-10 10 AMPULE in 1 CARTON (0641-6020-10) / 10 mL in 1 AMPULE (0641-6020-01)

Ingredients (1)

morphine sulfate (.5 mg/mL)

Linked Drug Pages (1)

Duramorph ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INTRATHECAL", "INTRAVENOUS"], "spl_id": "aa74af85-7068-4254-9a79-c7f3792044a6", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["892473", "892489", "1728783", "1728800"], "spl_set_id": ["ebb18761-e5c4-4238-bb84-f9549f500210"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 CARTON (0641-6020-10)  / 10 mL in 1 AMPULE (0641-6020-01)", "package_ndc": "0641-6020-10", "marketing_start_date": "19840918"}], "brand_name": "Duramorph", "product_id": "0641-6020_aa74af85-7068-4254-9a79-c7f3792044a6", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6020", "dea_schedule": "CII", "generic_name": "morphine sulfate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Duramorph", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": ".5 mg/mL"}], "application_number": "NDA018565", "marketing_category": "NDA", "marketing_start_date": "19840918", "listing_expiration_date": "20271231"}