Methocarbamol Tablets, USP, 500 mg

Product NDC
10135-722
11-digit product format
101350722
Labeler code
10135
Product ID
10135-722_441fa8ee-c4b7-d58f-e063-6394a90a3229
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA212623
Marketing category
ANDA
Marketing start
2021-12-09
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 Tablets, USP, 500 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL500 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
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-722-01Methocarbamol Tablets, USP, 500 mg100 in 1 BOTTLETABLET, FILM COATED1005
10135-722-05Methocarbamol Tablets, USP, 500 mg500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-722-01EA - Each10135-722e98158d9-36e0-4484-b52f-a9ac2935789712022-01-06
10135-722-05EA - Each10135-7224ab58456-5fff-48b5-a697-a6d11b393bfc12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-722METHOCARBAMOL TABLETS, USP, 500 MG (METHOCARBAMOL) TABLET, FILM COATED METHOCARBAMOL TABLETS, USP, 750 MG (METHOCARBAMOL) TABLET, FILM COATED [MARLEX PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20241010_d2e38ac9-1cf3-14ca-e053-2a95a90a8522.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSNd2e38ac9-1cf3-14ca-e053-2a95a90a85225
197944methocarbamol 750 MG Oral TabletPSNd2e38ac9-1cf3-14ca-e053-2a95a90a85225
197943methocarbamol 500 MG Oral TabletSCDd2e38ac9-1cf3-14ca-e053-2a95a90a85225
197944methocarbamol 750 MG Oral TabletSCDd2e38ac9-1cf3-14ca-e053-2a95a90a85225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10135-722-0110135072201100 TABLET, FILM COATED in 1 BOTTLE (10135-722-01) 2021-12-090000-00-00NoNoCurrent
10135-722-0510135072205500 TABLET, FILM COATED in 1 BOTTLE (10135-722-05) 2021-12-090000-00-00NoNoCurrent