FDA.reportPublic FDA data

Methocarbamol

Product NDC
69584-612
11-digit product format
695840612
Labeler code
69584
Product ID
69584-612_869612eb-80c5-498d-b4c1-a4f26e93a542
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Oxford Pharmaceuticals, LLC
Application
ANDA040489
Marketing category
ANDA
Marketing start
2019-08-15
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197943, 197944

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69584-612-01Methocarbamol10 in 1 BOTTLETABLET105
69584-612-09Methocarbamol90 in 1 BOTTLETABLET905
69584-612-10Methocarbamol100 in 1 BOTTLETABLET1005
69584-612-50Methocarbamol500 in 1 BOTTLETABLET5005
69584-612-90Methocarbamol1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-612-10EA - Each69584-6128c85fe67-c78f-4396-8604-4cb5ef44745a12019-10-07
69584-612-50EA - Each69584-612adf3f471-459a-48c3-86fa-d0e7aa2b746412019-10-07
69584-612-90EA - Each69584-612da9f17a3-72c7-4045-b9cc-62a1a04b7b5612023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-612METHOCARBAMOL TABLET [OXFORD PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 5 package rows20240308_06dc72a6-ef3a-425a-9194-a9d228093cc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN8c18ffef-b2c5-4af2-af66-e22c168e7680106
197944methocarbamol 750 MG Oral TabletSCD8c18ffef-b2c5-4af2-af66-e22c168e7680106
197944methocarbamol 750 MG Oral TabletPSN33f89a57-f65d-4e99-a3a3-690ef805d869105
197944methocarbamol 750 MG Oral TabletSCD33f89a57-f65d-4e99-a3a3-690ef805d869105
197944methocarbamol 750 MG Oral TabletPSN3f8aed5d-ba8d-4c32-872b-08ab15240cc1102
197944methocarbamol 750 MG Oral TabletPSNcc004f5c-d5fc-48c5-9f37-c59b9c37e113102
197944methocarbamol 750 MG Oral TabletSCD3f8aed5d-ba8d-4c32-872b-08ab15240cc1102
197944methocarbamol 750 MG Oral TabletSCDcc004f5c-d5fc-48c5-9f37-c59b9c37e113102
197944methocarbamol 750 MG Oral TabletPSNadb49cb7-8900-44dc-add0-22e2cd8235ac8
197944methocarbamol 750 MG Oral TabletSCDadb49cb7-8900-44dc-add0-22e2cd8235ac8
197944methocarbamol 750 MG Oral TabletPSN3d4a2486-863e-4e9f-be3b-67882863e7d47
197944methocarbamol 750 MG Oral TabletPSNafc9d84d-c8dd-05c0-e053-2a95a90a22a27
197944methocarbamol 750 MG Oral TabletSCD3d4a2486-863e-4e9f-be3b-67882863e7d47
197944methocarbamol 750 MG Oral TabletSCDafc9d84d-c8dd-05c0-e053-2a95a90a22a27
197944methocarbamol 750 MG Oral TabletPSNd8e3f8dc-9751-419b-8601-d85c43415c826
197944methocarbamol 750 MG Oral TabletSCDd8e3f8dc-9751-419b-8601-d85c43415c826
197943methocarbamol 500 MG Oral TabletPSN06dc72a6-ef3a-425a-9194-a9d228093cc45
197944methocarbamol 750 MG Oral TabletPSNd217bd1d-0b6e-4a4c-a47b-de73b94e8b135
197944methocarbamol 750 MG Oral TabletPSN4ef1c2c0-31e1-4f85-b645-ff47a057a9945
197944methocarbamol 750 MG Oral TabletPSN06dc72a6-ef3a-425a-9194-a9d228093cc45
197943methocarbamol 500 MG Oral TabletSCD06dc72a6-ef3a-425a-9194-a9d228093cc45
197944methocarbamol 750 MG Oral TabletSCD06dc72a6-ef3a-425a-9194-a9d228093cc45
197944methocarbamol 750 MG Oral TabletSCDd217bd1d-0b6e-4a4c-a47b-de73b94e8b135
197944methocarbamol 750 MG Oral TabletSCD4ef1c2c0-31e1-4f85-b645-ff47a057a9945
197944methocarbamol 750 MG Oral TabletPSNfd8cac57-9664-1fa0-e053-6294a90af8723
197944methocarbamol 750 MG Oral TabletPSN5a9b1104-4c9a-4c8c-9e24-719a7b3a89d73
197944methocarbamol 750 MG Oral TabletSCDfd8cac57-9664-1fa0-e053-6294a90af8723
197944methocarbamol 750 MG Oral TabletSCD5a9b1104-4c9a-4c8c-9e24-719a7b3a89d73
197944methocarbamol 750 MG Oral TabletPSNcff9b44c-618c-4beb-e053-2a95a90a24b02
197944methocarbamol 750 MG Oral TabletPSNf40f77aa-7bd3-4899-e053-2995a90a84862
197944methocarbamol 750 MG Oral TabletSCDcff9b44c-618c-4beb-e053-2a95a90a24b02
197944methocarbamol 750 MG Oral TabletSCDf40f77aa-7bd3-4899-e053-2995a90a84862
197943methocarbamol 500 MG Oral TabletPSN6155b45d-3ad3-4ca4-a6ee-42885414c0e11
197943methocarbamol 500 MG Oral TabletPSNe4ebe9cf-a274-47c7-b740-4b3d6e9dc52b1
197944methocarbamol 750 MG Oral TabletPSNca5153da-e921-0bc4-e053-2995a90ac6aa1
197944methocarbamol 750 MG Oral TabletPSNca5060d8-4d38-7c19-e053-2995a90a3bdb1
197944methocarbamol 750 MG Oral TabletPSN2cf76cdc-820d-1c5b-e063-6294a90a35aa1
197944methocarbamol 750 MG Oral TabletPSNe4ebe9cf-a274-47c7-b740-4b3d6e9dc52b1
197944methocarbamol 750 MG Oral TabletPSN6155b45d-3ad3-4ca4-a6ee-42885414c0e11
197943methocarbamol 500 MG Oral TabletSCDe4ebe9cf-a274-47c7-b740-4b3d6e9dc52b1
197943methocarbamol 500 MG Oral TabletSCD6155b45d-3ad3-4ca4-a6ee-42885414c0e11
197944methocarbamol 750 MG Oral TabletSCDca5153da-e921-0bc4-e053-2995a90ac6aa1
197944methocarbamol 750 MG Oral TabletSCD2cf76cdc-820d-1c5b-e063-6294a90a35aa1
197944methocarbamol 750 MG Oral TabletSCDca5060d8-4d38-7c19-e053-2995a90a3bdb1
197944methocarbamol 750 MG Oral TabletSCDe4ebe9cf-a274-47c7-b740-4b3d6e9dc52b1
197944methocarbamol 750 MG Oral TabletSCD6155b45d-3ad3-4ca4-a6ee-42885414c0e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69584-612-016958406120110 TABLET in 1 BOTTLE (69584-612-01) 10 tablet2019-08-150000-00-00NoNoCurrent
69584-612-096958406120990 TABLET in 1 BOTTLE (69584-612-09) 90 tablet2019-08-150000-00-00NoNoCurrent
69584-612-1069584061210100 TABLET in 1 BOTTLE (69584-612-10) 100 tablet2019-08-150000-00-00NoNoCurrent
69584-612-5069584061250500 TABLET in 1 BOTTLE (69584-612-50) 500 tablet2019-08-150000-00-00NoNoCurrent
69584-612-90695840612901000 TABLET in 1 BOTTLE (69584-612-90) 1000 tablet2019-08-150000-00-00NoNoCurrent