morphine sulfate extended release

Generic: morphine sulfate

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name morphine sulfate extended release
Generic Name morphine sulfate
Labeler american health packaging
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

morphine sulfate 30 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-158
Product ID 68084-158_2a816b7d-8695-f031-e063-6294a90a3654
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074862
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2013-09-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084158
Hyphenated Format 68084-158

Supplemental Identifiers

RxCUI
891881 891888
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 extended release (source: ndc)
Generic Name morphine sulfate (source: ndc)
Application Number ANDA074862 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-158-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-158-11)
source: ndc

Packages (1)

68084-158-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-158-01) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-158-11)

Ingredients (1)

morphine sulfate (30 mg/1)

Linked Drug Pages (1)

Morphine Sulfate Extended Release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a816b7d-8695-f031-e063-6294a90a3654", "openfda": {"unii": ["X3P646A2J0"], "rxcui": ["891881", "891888"], "spl_set_id": ["f915420d-981d-455b-b4cf-67c8e201a136"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-158-01)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-158-11)", "package_ndc": "68084-158-01", "marketing_start_date": "20130926"}], "brand_name": "Morphine Sulfate Extended Release", "product_id": "68084-158_2a816b7d-8695-f031-e063-6294a90a3654", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "68084-158", "dea_schedule": "CII", "generic_name": "Morphine Sulfate", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Morphine Sulfate", "brand_name_suffix": "Extended Release", "active_ingredients": [{"name": "MORPHINE SULFATE", "strength": "30 mg/1"}], "application_number": "ANDA074862", "marketing_category": "ANDA", "marketing_start_date": "20130926", "listing_expiration_date": "20261231"}