FDA.reportPublic FDA data

Methocarbamol

Product NDC
80425-0020
11-digit product format
804250020
Labeler code
80425
Product ID
80425-0020_2a987a87-35eb-e046-e063-6294a90aa7c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA209312
Marketing category
ANDA
Marketing start
2018-07-02
Substance
METHOCARBAMOL
Active strength
750 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
METHOCARBAMOL750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197944

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
80425-0020-1Methocarbamol30 in 1 BOTTLETABLET, COATED307
80425-0020-2Methocarbamol60 in 1 BOTTLETABLET, COATED607
80425-0020-3Methocarbamol90 in 1 BOTTLETABLET, COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0020-1EA - Each80425-002040e4b681-d5f4-4428-9cbc-c98d2af3dced12023-06-06
80425-0020-2EA - Each80425-00203b446848-3616-47b2-8eea-793b382196c612023-06-06
80425-0020-3EA - Each80425-00206571d278-87cd-45a1-b025-4c1e7eb1d04312023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0020METHOCARBAMOL TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_af73ae4b-bcf5-2e21-e053-2a95a90a2dce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSNaf73ae4b-bcf5-2e21-e053-2a95a90a2dce7
197944methocarbamol 750 MG Oral TabletSCDaf73ae4b-bcf5-2e21-e053-2a95a90a2dce7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0020-18042500200130 TABLET, COATED in 1 BOTTLE (80425-0020-1) 2018-07-020000-00-00NoNoCurrent
80425-0020-28042500200260 TABLET, COATED in 1 BOTTLE (80425-0020-2) 2018-07-020000-00-00NoNoCurrent
80425-0020-38042500200390 TABLET, COATED in 1 BOTTLE (80425-0020-3) 2018-07-02NoNoCurrent