FDA.reportPublic FDA data

Methocarbamol

Product NDC
85509-2910
11-digit product format
855092910
Labeler code
85509
Product ID
85509-2910_4abc30c4-d454-3908-e063-6394a90a555b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA040489
Marketing category
ANDA
Marketing start
2025-05-22
Substance
METHOCARBAMOL
Active strength
500 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
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
85509-2910-1Methocarbamol100 in 1 BOTTLETABLET1001
85509-2910-3Methocarbamol30 in 1 BOTTLETABLET301
85509-2910-6Methocarbamol60 in 1 BOTTLETABLET601
85509-2910-9Methocarbamol90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-2910-1EA - Each85509-29101d9a11a1-ef53-47cd-a140-e0bd12b48d1512026-03-17
85509-2910-3EA - Each85509-29100e3d08e5-456e-4e44-85a4-c69f7f773beb12026-03-17
85509-2910-6EA - Each85509-29100196e92f-612b-4a00-a338-a974032be8ca12026-03-17
85509-2910-9EA - Each85509-291011e85054-997d-41ad-b822-a7db46346ac312026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN4abc29e9-a0cc-06cf-e063-6294a90ad8741
197943methocarbamol 500 MG Oral TabletSCD4abc29e9-a0cc-06cf-e063-6294a90ad8741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85509-2910-185509291001100 TABLET in 1 BOTTLE (85509-2910-1) 100 tablet2026-02-13NoNoHistorical
85509-2910-38550929100330 TABLET in 1 BOTTLE (85509-2910-3) 30 tablet2026-02-13NoNoHistorical
85509-2910-68550929100660 TABLET in 1 BOTTLE (85509-2910-6) 60 tablet2026-02-13NoNoHistorical
85509-2910-98550929100990 TABLET in 1 BOTTLE (85509-2910-9) 90 tablet2026-02-13NoNoHistorical