FDA.reportPublic FDA data

Methocarbamol

Product NDC
71335-0828
11-digit product format
713350828
Labeler code
71335
Product ID
71335-0828_06fc4abf-86b7-43ce-b5de-0a055aae2025
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208507
Marketing category
ANDA
Marketing start
2018-01-15
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL750 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
71335-0828-0Methocarbamol14 in 1 BOTTLETABLET, FILM COATED146
71335-0828-1Methocarbamol20 in 1 BOTTLETABLET, FILM COATED206
71335-0828-2Methocarbamol30 in 1 BOTTLETABLET, FILM COATED306
71335-0828-3Methocarbamol40 in 1 BOTTLETABLET, FILM COATED406
71335-0828-4Methocarbamol120 in 1 BOTTLETABLET, FILM COATED1206
71335-0828-5Methocarbamol60 in 1 BOTTLETABLET, FILM COATED606
71335-0828-6Methocarbamol90 in 1 BOTTLETABLET, FILM COATED906
71335-0828-7Methocarbamol112 in 1 BOTTLETABLET, FILM COATED1126
71335-0828-8Methocarbamol21 in 1 BOTTLETABLET, FILM COATED216
71335-0828-9Methocarbamol84 in 1 BOTTLETABLET, FILM COATED846

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0828-1EA - Each71335-0828523ede68-3cb3-4aea-a755-4f2dac81298912021-02-05
71335-0828-2EA - Each71335-082813aea9a6-0ea6-44a2-bf6c-db18b1caa99d12021-02-05
71335-0828-3EA - Each71335-0828519f8055-345d-4477-a36b-049beb5a71a112021-02-05
71335-0828-4EA - Each71335-0828fc5897ef-2647-4d26-8978-0026c026ae4f12021-02-05
71335-0828-5EA - Each71335-0828608ae9a4-7a8c-4c40-935e-3297cc52670312018-09-05
71335-0828-6EA - Each71335-0828222d7dff-a803-4685-831f-fc89e90f4df012021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0828METHOCARBAMOL TABLET, FILM COATED [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20240509_3212f121-9428-4186-8f00-accf08bca473.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN3212f121-9428-4186-8f00-accf08bca4737
197944methocarbamol 750 MG Oral TabletPSN3212f121-9428-4186-8f00-accf08bca4737
197943methocarbamol 500 MG Oral TabletSCD3212f121-9428-4186-8f00-accf08bca4737
197944methocarbamol 750 MG Oral TabletSCD3212f121-9428-4186-8f00-accf08bca4737

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0828-07133508280014 TABLET, FILM COATED in 1 BOTTLE (71335-0828-0) 2018-01-150000-00-00NoNoCurrent
71335-0828-17133508280120 TABLET, FILM COATED in 1 BOTTLE (71335-0828-1) 2018-01-150000-00-00NoNoCurrent
71335-0828-27133508280230 TABLET, FILM COATED in 1 BOTTLE (71335-0828-2) 2018-01-150000-00-00NoNoCurrent
71335-0828-37133508280340 TABLET, FILM COATED in 1 BOTTLE (71335-0828-3) 2018-01-150000-00-00NoNoCurrent
71335-0828-471335082804120 TABLET, FILM COATED in 1 BOTTLE (71335-0828-4) 2018-01-150000-00-00NoNoCurrent
71335-0828-57133508280560 TABLET, FILM COATED in 1 BOTTLE (71335-0828-5) 2018-01-150000-00-00NoNoCurrent
71335-0828-67133508280690 TABLET, FILM COATED in 1 BOTTLE (71335-0828-6) 2018-01-150000-00-00NoNoCurrent
71335-0828-771335082807112 TABLET, FILM COATED in 1 BOTTLE (71335-0828-7) 2018-01-150000-00-00NoNoCurrent
71335-0828-87133508280821 TABLET, FILM COATED in 1 BOTTLE (71335-0828-8) 2018-01-150000-00-00NoNoCurrent
71335-0828-97133508280984 TABLET, FILM COATED in 1 BOTTLE (71335-0828-9) 2018-01-150000-00-00NoNoCurrent