FDA.reportPublic FDA data

Methocarbamol

Product NDC
43063-905
11-digit product format
430630905
Labeler code
43063
Product ID
43063-905_32d38d53-d181-0b14-e063-6394a90ae577
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA209312
Marketing category
ANDA
Marketing start
2018-07-02
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197944

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
43063-905-14Methocarbamol14 in 1 BOTTLE, PLASTICTABLET, COATED1417
43063-905-20Methocarbamol20 in 1 BOTTLE, PLASTICTABLET, COATED2017
43063-905-30Methocarbamol30 in 1 BOTTLE, PLASTICTABLET, COATED3017
43063-905-40Methocarbamol40 in 1 BOTTLE, PLASTICTABLET, COATED4017
43063-905-60Methocarbamol60 in 1 BOTTLE, PLASTICTABLET, COATED6017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-905-14EA - Each43063-905b2163e81-9563-42aa-95b9-3e3a922c87f812019-01-24
43063-905-20EA - Each43063-90598c68f06-a6e2-4fa6-a9f5-59e290fa915c12019-01-24
43063-905-30EA - Each43063-90533d3716d-05a5-4e4d-86f2-b727d388928612019-01-24
43063-905-40EA - Each43063-9053f5cfbd7-d4bb-4d34-9430-81a31d83363a12019-01-24
43063-905-60EA - Each43063-905d7f0e9a2-bca9-43df-a376-928eeeb691b712019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-905METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 5 package rows20250417_d0acdf52-e1a9-4489-91e1-ef434d311613.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSNd0acdf52-e1a9-4489-91e1-ef434d31161317
197944methocarbamol 750 MG Oral TabletSCDd0acdf52-e1a9-4489-91e1-ef434d31161317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-905-144306309051414 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-905-14) 2018-11-080000-00-00NoNoCurrent
43063-905-204306309052020 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-905-20) 2018-11-080000-00-00NoNoCurrent
43063-905-304306309053030 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-905-30) 2018-11-080000-00-00NoNoCurrent
43063-905-404306309054040 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-905-40) 2018-11-120000-00-00NoNoCurrent
43063-905-604306309056060 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-905-60) 2019-01-090000-00-00NoNoCurrent