FDA.reportPublic FDA data

Methocarbamol

Product NDC
85509-1910
11-digit product format
855091910
Labeler code
85509
Product ID
85509-1910_437dd17b-db52-8080-e063-6394a90abb28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA040489
Marketing category
ANDA
Marketing start
2021-01-01
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
Listing expiration
2026-12-31

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
85509-1910-1Methocarbamol100 in 1 BOTTLETABLET1002
85509-1910-3Methocarbamol30 in 1 BOTTLETABLET302
85509-1910-6Methocarbamol60 in 1 BOTTLETABLET602
85509-1910-9Methocarbamol90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1910-1EA - Each85509-1910eac5ede6-0752-4d31-a6d7-1986c656ea7f12025-09-12
85509-1910-3EA - Each85509-191041a6ea26-1c58-4b42-9751-dfd716d4728412025-12-16
85509-1910-6EA - Each85509-19101cc72334-f95f-4389-9f78-4c97abc06c1f12025-09-12
85509-1910-9EA - Each85509-1910655b766d-794a-441b-8151-6176e9c8a98e12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN39bc9ecf-837e-5bb8-e063-6394a90a917e2
197943methocarbamol 500 MG Oral TabletSCD39bc9ecf-837e-5bb8-e063-6394a90a917e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85509-1910-185509191001100 TABLET in 1 BOTTLE (85509-1910-1) 100 tablet2025-07-11NoNoHistorical
85509-1910-38550919100330 TABLET in 1 BOTTLE (85509-1910-3) 30 tablet2025-11-11NoNoHistorical
85509-1910-68550919100660 TABLET in 1 BOTTLE (85509-1910-6) 60 tablet2025-07-14NoNoHistorical
85509-1910-98550919100990 TABLET in 1 BOTTLE (85509-1910-9) 90 tablet2025-07-14NoNoHistorical