meperidine hydrochloride

Generic: meperidine hydrochloride

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

Drug Facts

Product Profile

Brand Name meperidine hydrochloride
Generic Name meperidine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

meperidine hydrochloride 50 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6053
Product ID 0641-6053_9566d54d-7343-4695-94ff-8b5f2d384c81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA080445
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 1975-01-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416053
Hyphenated Format 0641-6053

Supplemental Identifiers

RxCUI
861476 1665685 1665697
UNII
N8E7F7Q170

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 meperidine hydrochloride (source: ndc)
Generic Name meperidine hydrochloride (source: ndc)
Application Number ANDA080445 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-6053-25) / 1 mL in 1 VIAL (0641-6053-01)
source: ndc

Packages (1)

0641-6053-25 25 VIAL in 1 CARTON (0641-6053-25) / 1 mL in 1 VIAL (0641-6053-01)

Ingredients (1)

meperidine hydrochloride (50 mg/mL)

Linked Drug Pages (1)

MEPERIDINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "9566d54d-7343-4695-94ff-8b5f2d384c81", "openfda": {"unii": ["N8E7F7Q170"], "rxcui": ["861476", "1665685", "1665697"], "spl_set_id": ["e0e998da-f056-4fce-be8e-ed60cf3b461b"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-6053-25)  / 1 mL in 1 VIAL (0641-6053-01)", "package_ndc": "0641-6053-25", "marketing_start_date": "19750122"}], "brand_name": "MEPERIDINE HYDROCHLORIDE", "product_id": "0641-6053_9566d54d-7343-4695-94ff-8b5f2d384c81", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6053", "dea_schedule": "CII", "generic_name": "MEPERIDINE HYDROCHLORIDE", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MEPERIDINE HYDROCHLORIDE", "active_ingredients": [{"name": "MEPERIDINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA080445", "marketing_category": "ANDA", "marketing_start_date": "19750122", "listing_expiration_date": "20261231"}