FDA.reportPublic FDA data

Methocarbamol

Product NDC
71335-0970
11-digit product format
713350970
Labeler code
71335
Product ID
71335-0970_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
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL500 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
71335-0970-0Methocarbamol15 in 1 BOTTLETABLET, FILM COATED156
71335-0970-1Methocarbamol14 in 1 BOTTLETABLET, FILM COATED146
71335-0970-2Methocarbamol30 in 1 BOTTLETABLET, FILM COATED306
71335-0970-3Methocarbamol20 in 1 BOTTLETABLET, FILM COATED206
71335-0970-4Methocarbamol60 in 1 BOTTLETABLET, FILM COATED606
71335-0970-5Methocarbamol100 in 1 BOTTLETABLET, FILM COATED1006
71335-0970-6Methocarbamol40 in 1 BOTTLETABLET, FILM COATED406
71335-0970-7Methocarbamol90 in 1 BOTTLETABLET, FILM COATED906
71335-0970-8Methocarbamol120 in 1 BOTTLETABLET, FILM COATED1206
71335-0970-9Methocarbamol7 in 1 BOTTLETABLET, FILM COATED76

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0970-4EA - Each71335-097056d4d80a-7e69-4880-8609-87ba0ca64b7a12019-05-02
71335-0970-7EA - Each71335-09709e6679b6-2ce1-49b2-b8b0-ef76433dbe0b12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0970METHOCARBAMOL 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
71335-0970-07133509700015 TABLET, FILM COATED in 1 BOTTLE (71335-0970-0) 2018-10-180000-00-00NoNoCurrent
71335-0970-17133509700114 TABLET, FILM COATED in 1 BOTTLE (71335-0970-1) 2018-10-180000-00-00NoNoCurrent
71335-0970-27133509700230 TABLET, FILM COATED in 1 BOTTLE (71335-0970-2) 2018-10-180000-00-00NoNoCurrent
71335-0970-37133509700320 TABLET, FILM COATED in 1 BOTTLE (71335-0970-3) 2018-10-180000-00-00NoNoCurrent
71335-0970-47133509700460 TABLET, FILM COATED in 1 BOTTLE (71335-0970-4) 2018-10-180000-00-00NoNoCurrent
71335-0970-571335097005100 TABLET, FILM COATED in 1 BOTTLE (71335-0970-5) 2018-10-180000-00-00NoNoCurrent
71335-0970-67133509700640 TABLET, FILM COATED in 1 BOTTLE (71335-0970-6) 2018-10-180000-00-00NoNoCurrent
71335-0970-77133509700790 TABLET, FILM COATED in 1 BOTTLE (71335-0970-7) 2018-10-180000-00-00NoNoCurrent
71335-0970-871335097008120 TABLET, FILM COATED in 1 BOTTLE (71335-0970-8) 2018-10-180000-00-00NoNoCurrent
71335-0970-9713350970097 TABLET, FILM COATED in 1 BOTTLE (71335-0970-9) 2018-10-180000-00-00NoNoCurrent