mitigo

Generic: morphine sulfate

Labeler: piramal critical care, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mitigo
Generic Name morphine sulfate
Labeler piramal critical care, inc.
Dosage Form INJECTION
Routes
EPIDURAL INTRATHECAL
Active Ingredients

morphine sulfate 200 mg/20mL

Manufacturer
Piramal Critical Care, Inc.

Identifiers & Regulatory

Product NDC 66794-160
Product ID 66794-160_495a6a51-d35d-2b96-e063-6394a90ac5f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204393
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2019-02-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66794160
Hyphenated Format 66794-160

Supplemental Identifiers

RxCUI
1731522 1731998 2055307 2055311
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 mitigo (source: ndc)
Generic Name morphine sulfate (source: ndc)
Application Number ANDA204393 (source: ndc)
Routes
EPIDURAL INTRATHECAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/20mL
source: ndc
Packaging
  • 1 mL in 1 VIAL, SINGLE-USE (66794-160-02)
source: ndc

Packages (1)

66794-160-02 1 mL in 1 VIAL, SINGLE-USE (66794-160-02)

Ingredients (1)

morphine sulfate (200 mg/20mL)

Linked Drug Pages (1)

MITIGO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INTRATHECAL"], "spl_id": "495a6a51-d35d-2b96-e063-6394a90ac5f3", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["1731522", "1731998", "2055307", "2055311"], "spl_set_id": ["728f3d83-9a63-0c1f-e053-2a91aa0ac7db"], "manufacturer_name": ["Piramal Critical Care, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 mL in 1 VIAL, SINGLE-USE (66794-160-02)", "package_ndc": "66794-160-02", "marketing_start_date": "20190225"}], "brand_name": "MITIGO", "product_id": "66794-160_495a6a51-d35d-2b96-e063-6394a90ac5f3", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "66794-160", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "Piramal Critical Care, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MITIGO", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "200 mg/20mL"}], "application_number": "ANDA204393", "marketing_category": "ANDA", "marketing_start_date": "20190225", "listing_expiration_date": "20271231"}