FDA.reportPublic FDA data

Methocarbamol

Product NDC
80425-0021
11-digit product format
804250021
Labeler code
80425
Product ID
80425-0021_2a9878c8-a143-224c-e063-6394a90a839d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, 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
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
80425-0021-1Methocarbamol30 in 1 BOTTLETABLET307
80425-0021-2Methocarbamol60 in 1 BOTTLETABLET607
80425-0021-3Methocarbamol90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0021-1EA - Each80425-0021e875bb78-faf4-4bf2-9e7d-1e69608aa45d12023-04-07
80425-0021-2EA - Each80425-0021b635daf9-5db2-4e57-9dc6-f4bc7ea00d9412023-04-07
80425-0021-3EA - Each80425-002166a52d92-5042-40f2-8cfb-29c3e06e3a4212023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0021METHOCARBAMOL TABLET [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_afc9d84d-c8dd-05c0-e053-2a95a90a22a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSNafc9d84d-c8dd-05c0-e053-2a95a90a22a27
197944methocarbamol 750 MG Oral TabletSCDafc9d84d-c8dd-05c0-e053-2a95a90a22a27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0021-18042500210130 TABLET in 1 BOTTLE (80425-0021-1) 30 tablet2019-08-150000-00-00NoNoCurrent
80425-0021-28042500210260 TABLET in 1 BOTTLE (80425-0021-2) 60 tablet2019-08-150000-00-00NoNoCurrent
80425-0021-38042500210390 TABLET in 1 BOTTLE (80425-0021-3) 90 tablet2019-08-150000-00-00NoNoCurrent