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 SOLUTION
Routes
ORAL
Active Ingredients

meperidine hydrochloride 50 mg/5mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-3545
Product ID 0054-3545_677fb454-d83d-4c3c-b095-a58a1c4781b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088744
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 1985-01-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00543545
Hyphenated Format 0054-3545

Supplemental Identifiers

RxCUI
861455 861467 861479
UPC
0300543545632
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 ANDA088744 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (0054-3545-63)
source: ndc

Packages (1)

0054-3545-63 500 mL in 1 BOTTLE (0054-3545-63)

Ingredients (1)

meperidine hydrochloride (50 mg/5mL)

Linked Drug Pages (1)

Meperidine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "677fb454-d83d-4c3c-b095-a58a1c4781b9", "openfda": {"upc": ["0300543545632"], "unii": ["N8E7F7Q170"], "rxcui": ["861455", "861467", "861479"], "spl_set_id": ["15bc51a8-1e24-4d33-9a2f-05a41c29acf0"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (0054-3545-63)", "package_ndc": "0054-3545-63", "marketing_start_date": "19850130"}], "brand_name": "Meperidine Hydrochloride", "product_id": "0054-3545_677fb454-d83d-4c3c-b095-a58a1c4781b9", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0054-3545", "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/5mL"}], "application_number": "ANDA088744", "marketing_category": "ANDA", "marketing_start_date": "19850130", "listing_expiration_date": "20271231"}