methocarbamol tablets, usp, 500 mg

Generic: methocarbamol

Labeler: marlex pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name methocarbamol tablets, usp, 500 mg
Generic Name methocarbamol
Labeler marlex pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

methocarbamol 500 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-722
Product ID 10135-722_441fa8ee-c4b7-d58f-e063-6394a90a3229
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212623
Listing Expiration 2026-12-31
Marketing Start 2021-12-09

Pharmacologic Class

Established (EPC)
muscle relaxant [epc]
Physiologic Effect
centrally-mediated muscle relaxation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135722
Hyphenated Format 10135-722

Supplemental Identifiers

RxCUI
197943 197944
UNII
125OD7737X
NUI
N0000175730 N0000175737

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 methocarbamol tablets, usp, 500 mg (source: ndc)
Generic Name methocarbamol (source: ndc)
Application Number ANDA212623 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (10135-722-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (10135-722-05)
source: ndc

Packages (2)

10135-722-01 100 TABLET, FILM COATED in 1 BOTTLE (10135-722-01) 10135-722-05 500 TABLET, FILM COATED in 1 BOTTLE (10135-722-05)

Ingredients (1)

methocarbamol (500 mg/1)

Linked Drug Pages (1)

Methocarbamol Tablets, USP, 500 mg, Methocarbamol Tablets, USP, 750 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "441fa8ee-c4b7-d58f-e063-6394a90a3229", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["125OD7737X"], "rxcui": ["197943", "197944"], "spl_set_id": ["d2e38ac9-1cf3-14ca-e053-2a95a90a8522"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (10135-722-01)", "package_ndc": "10135-722-01", "marketing_start_date": "20211209"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (10135-722-05)", "package_ndc": "10135-722-05", "marketing_start_date": "20211209"}], "brand_name": "Methocarbamol Tablets, USP, 500 mg", "product_id": "10135-722_441fa8ee-c4b7-d58f-e063-6394a90a3229", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "10135-722", "generic_name": "Methocarbamol", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Methocarbamol Tablets, USP, 500 mg", "active_ingredients": [{"name": "METHOCARBAMOL", "strength": "500 mg/1"}], "application_number": "ANDA212623", "marketing_category": "ANDA", "marketing_start_date": "20211209", "listing_expiration_date": "20261231"}