FDA.reportPublic FDA data

Methocarbamol

Product NDC
63629-1622
11-digit product format
636291622
Labeler code
63629
Product ID
63629-1622_c77bc09b-efdc-4ce5-89b8-ebb328d3599a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090200
Marketing category
ANDA
Marketing start
2013-03-20
Substance
METHOCARBAMOL
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197943

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1622-0Methocarbamol15 in 1 BOTTLETABLET1526
63629-1622-1Methocarbamol14 in 1 BOTTLETABLET1426
63629-1622-2Methocarbamol30 in 1 BOTTLETABLET3026
63629-1622-3Methocarbamol20 in 1 BOTTLETABLET2026
63629-1622-4Methocarbamol60 in 1 BOTTLETABLET6026
63629-1622-5Methocarbamol100 in 1 BOTTLETABLET10026
63629-1622-6Methocarbamol40 in 1 BOTTLETABLET4026
63629-1622-7Methocarbamol90 in 1 BOTTLETABLET9026
63629-1622-8Methocarbamol120 in 1 BOTTLETABLET12026
63629-1622-9Methocarbamol7 in 1 BOTTLETABLET726

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1622-1EA - Each63629-162242b99229-4b99-4e14-8599-0f2016a258d912012-07-24
63629-1622-2EA - Each63629-16225990bc48-f4bd-4611-8637-473f262c26ef12012-07-24
63629-1622-3EA - Each63629-16229152f399-cff2-444b-a603-420c80c323cd12012-07-24
63629-1622-4EA - Each63629-16228dcb27cd-2702-4c30-9893-62018f18e11912012-07-24
63629-1622-5EA - Each63629-16220d46fce7-f2a7-42c6-94d6-c688c15c937112015-02-02
63629-1622-6EA - Each63629-1622aa3753bb-326c-4d5b-9060-449b141e471e12015-02-02
63629-1622-7EA - Each63629-1622ea3db8c3-1578-4176-a6ff-2b2248f9924912015-02-02
63629-1622-8EA - Each63629-16226e06ddc6-472d-467e-a32b-f7d2f91e374b12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]5
METHOCARBAMOLACTIVE MOIETY125OD7737XMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOCARBAMOL TABLET [BRYANT RANCH PREPACK]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]5
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHOCARBAMOL TABLET [BRYANT RANCH PREPACK]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHOCARBAMOL TABLET [BRYANT RANCH PREPACK]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1622METHOCARBAMOL (METHOCARBAMOL) TABLET [BRYANT RANCH PREPACK]26Current NDC, Legacy NDC, 10 package rows20240821_add9e47f-11ac-e10d-bfc2-b9c52aa08fa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSNadd9e47f-11ac-e10d-bfc2-b9c52aa08fa526
197943methocarbamol 500 MG Oral TabletSCDadd9e47f-11ac-e10d-bfc2-b9c52aa08fa526

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1622-06362916220015 TABLET in 1 BOTTLE (63629-1622-0) 15 tablet2021-12-210000-00-00NoNoCurrent
63629-1622-16362916220114 TABLET in 1 BOTTLE (63629-1622-1) 14 tablet2015-04-240000-00-00NoNoCurrent
63629-1622-26362916220230 TABLET in 1 BOTTLE (63629-1622-2) 30 tablet2021-12-210000-00-00NoNoCurrent
63629-1622-36362916220320 TABLET in 1 BOTTLE (63629-1622-3) 20 tablet2021-12-210000-00-00NoNoCurrent
63629-1622-46362916220460 TABLET in 1 BOTTLE (63629-1622-4) 60 tablet2021-12-210000-00-00NoNoCurrent
63629-1622-563629162205100 TABLET in 1 BOTTLE (63629-1622-5) 100 tablet2015-03-160000-00-00NoNoCurrent
63629-1622-66362916220640 TABLET in 1 BOTTLE (63629-1622-6) 40 tablet2021-12-210000-00-00NoNoCurrent
63629-1622-76362916220790 TABLET in 1 BOTTLE (63629-1622-7) 90 tablet2021-12-210000-00-00NoNoCurrent
63629-1622-863629162208120 TABLET in 1 BOTTLE (63629-1622-8) 120 tablet2021-12-210000-00-00NoNoCurrent
63629-1622-9636291622097 TABLET in 1 BOTTLE (63629-1622-9) 7 tablet2021-12-210000-00-00NoNoCurrent