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Methocarbamol

Methocarbamol Tablets 500mg

Approved
Approval ID

cf931001-95bd-4900-98d5-f5ef54b49d99

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 17, 2023

Manufacturers
FDA

Key Therapeutics

DUNS: 080318791

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

methocarbamol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70868-910
Application NumberANDA040489
Product Classification
M
Marketing Category
C73584
G
Generic Name
methocarbamol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification

INGREDIENTS (8)

MethocarbamolActive
Quantity: 500 mg in 1 1
Code: 125OD7737X
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
Povidone K90Inactive
Code: RDH86HJV5Z
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/17/2023

Methocarbamol Tablets, USP 500 mg

Rx only

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Methocarbamol - FDA Drug Approval Details