metoclopramide hydrochloride

Generic: metoclopramide hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metoclopramide hydrochloride
Generic Name metoclopramide hydrochloride
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

metoclopramide hydrochloride 5 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-526
Product ID 62135-526_49dc78f2-e942-afb5-e063-6394a90a20d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073680
Listing Expiration 2027-12-31
Marketing Start 1992-10-27

Pharmacologic Class

Classes
dopamine d2 antagonists [moa] dopamine-2 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135526
Hyphenated Format 62135-526

Supplemental Identifiers

RxCUI
104884
UPC
0362135526474
UNII
W1792A2RVD

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 metoclopramide hydrochloride (source: ndc)
Generic Name metoclopramide hydrochloride (source: ndc)
Application Number ANDA073680 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-526-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10)
  • 473 mL in 1 BOTTLE (62135-526-47)
source: ndc

Packages (2)

62135-526-24 2 TRAY in 1 BOX (62135-526-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10) 62135-526-47 473 mL in 1 BOTTLE (62135-526-47)

Ingredients (1)

metoclopramide hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

metoclopramide hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49dc78f2-e942-afb5-e063-6394a90a20d5", "openfda": {"upc": ["0362135526474"], "unii": ["W1792A2RVD"], "rxcui": ["104884"], "spl_set_id": ["dc364325-dd39-4259-a348-3760eccdca4b"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-526-24)  / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10)", "package_ndc": "62135-526-24", "marketing_start_date": "20241014"}, {"sample": false, "description": "473 mL in 1 BOTTLE (62135-526-47)", "package_ndc": "62135-526-47", "marketing_start_date": "20230321"}], "brand_name": "metoclopramide hydrochloride", "product_id": "62135-526_49dc78f2-e942-afb5-e063-6394a90a20d5", "dosage_form": "SOLUTION", "pharm_class": ["Dopamine D2 Antagonists [MoA]", "Dopamine-2 Receptor Antagonist [EPC]"], "product_ndc": "62135-526", "generic_name": "metoclopramide hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "metoclopramide hydrochloride", "active_ingredients": [{"name": "METOCLOPRAMIDE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA073680", "marketing_category": "ANDA", "marketing_start_date": "19921027", "listing_expiration_date": "20271231"}