FDA.reportPublic FDA data

Methocarbamol

Product NDC
72789-021
11-digit product format
727890021
Labeler code
72789
Product ID
72789-021_4af30668-89af-69a1-e063-6394a90a38f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
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
72789-021-01Methocarbamol100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016
72789-021-60Methocarbamol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6016
72789-021-82Methocarbamol500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50016
72789-021-90Methocarbamol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9016
72789-021-93Methocarbamol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18016
72789-021-94Methocarbamol270 in 1 BOTTLE, PLASTICTABLET, FILM COATED27016
72789-021-99Methocarbamol240 in 1 BOTTLE, PLASTICTABLET, FILM COATED24016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-021-01EA - Each72789-021a847298d-cc94-4292-9d8f-afc21ff4b9d612019-11-12
72789-021-60EA - Each72789-02146b1621a-f7da-4de2-bc1c-e18160fa767312023-10-16
72789-021-82EA - Each72789-021eae9dd32-b8f2-4e9c-8e20-9bd001c1eca512019-11-12
72789-021-90EA - Each72789-0219159b07e-4ecd-4d61-b819-810394a8bdda12023-08-08
72789-021-93EA - Each72789-021694c4ac1-9a68-41d5-9a73-901be4e58c4712023-10-16
72789-021-94EA - Each72789-0212367ee84-da9e-4fe7-9c9e-0b7af81ae33012023-10-16
72789-021-99EA - Each72789-02133c0066b-0c53-488a-872d-ee34448d287a12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-021METHOCARBAMOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 7 package rows20240417_943fe701-5d7d-4abe-a529-c5a548e94bc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN943fe701-5d7d-4abe-a529-c5a548e94bc616
197943methocarbamol 500 MG Oral TabletSCD943fe701-5d7d-4abe-a529-c5a548e94bc616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-021-0172789002101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-01) 2019-10-240000-00-00NoNoCurrent
72789-021-607278900216060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-60) 2023-09-12NoNoCurrent
72789-021-8272789002182500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-82) 2019-10-240000-00-00NoNoCurrent
72789-021-907278900219090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-90) 2023-09-12NoNoCurrent
72789-021-9372789002193180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-93) 2019-10-24NoNoCurrent
72789-021-9472789002194270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-94) 2019-10-24NoNoCurrent
72789-021-9972789002199240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-99) 2019-10-24NoNoCurrent