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NDC 61919-0627-90 METHOCARBAMOL 750 mg/1 Details

METHOCARBAMOL 750 mg/1

METHOCARBAMOL is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by DirectRX. The primary component is METHOCARBAMOL.

MedlinePlus Drug Summary

Methocarbamol is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Methocarbamol is in a class of medications called muscle relaxants. It works by slowing activity in the nervous system to allow the body to relax

Related Packages: 61919-0627-90
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Methocarbamol

Product Information

NDC	61919-0627
Product ID	61919-627_87388b8c-daa4-3fbb-e053-2a91aa0a3e9b
Associated GPIs	75100070000310
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	METHOCARBAMOL
Proprietary Name Suffix	n/a
Non-Proprietary Name	METHOCARBAMOL
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	750
Active Ingredient Units	mg/1
Substance Name	METHOCARBAMOL
Labeler Name	DirectRX
Pharmaceutical Class	Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA200958
Listing Certified Through	2023-12-31

Package

Package Images

NDC 61919-0627-90 (61919062790)

Pricing Information	N/A
NDC Package Code	61919-627-90
Billing NDC	61919062790
Package	90 TABLET, FILM COATED in 1 BOTTLE (61919-627-90)
Marketing Start Date	2015-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 270b68a6-1469-190d-e054-00144ff8d46c Details

Description

Clinical Pharmacology

Pharmacokinetics

Elderly

Special Populations

The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (± SD) elimination half-life in these two groups was similar: 1.2 (± 0.6) versus 1.1 (± 0.3) hours, respectively.

Indications and Usage

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

How supplied

SPL Unclassified

Package Label

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

METHOCARBAMOL

methocarbamol tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:61919-627(NDC:76439-135)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)	METHOCARBAMOL	750 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TRIACETIN (UNII: XHX3C3X673)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	yellow	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	AP211
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61919-627-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA200958	01/01/2015

METHOCARBAMOL

methocarbamol tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:61919-610(NDC:70010-754)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)	METHOCARBAMOL	500 mg

Ingredient Name	Strength
Inactive Ingredients
POVIDONE (UNII: FZ989GH94E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	orange	Score	2 pieces
Shape	ROUND	Size	13mm
Flavor		Imprint Code	G;500
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61919-610-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	04/18/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209312	04/18/2019

METHOCARBAMOL

methocarbamol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:61919-903(NDC:31722-534)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)	METHOCARBAMOL	750 mg

Ingredient Name	Strength
Inactive Ingredients
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE K90 (UNII: RDH86HJV5Z)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white (White to Offwhite)	Score	no score
Shape	OVAL (Capsule shaped)	Size	19mm
Flavor		Imprint Code	115;H
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61919-903-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	04/23/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090200	04/23/2019

Labeler - DirectRX (079254320)

Name	Address	ID/FEI	Business Operations
Establishment
DirectRX		079254320	repack(61919-627, 61919-903) , relabel(61919-610)

Revised: 4/2019

Document Id: 87388b8c-daa4-3fbb-e053-2a91aa0a3e9b

Set id: 270b68a6-1469-190d-e054-00144ff8d46c

Version: 4

Effective Time: 20190423

Search by Drug Name or NDC

NDC 61919-0627-90 METHOCARBAMOL 750 mg/1 Details

METHOCARBAMOL 750 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 61919-0627-90 (61919062790)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 270b68a6-1469-190d-e054-00144ff8d46c Details

Description

Clinical Pharmacology

Pharmacokinetics

Elderly

Special Populations

Indications and Usage

Contraindications

Warnings

Precautions

Adverse Reactions

Overdosage

Dosage and Administration

How supplied

SPL Unclassified

Package Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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