FDA.reportPublic FDA data

Methocarbamol

Product NDC
71205-068
11-digit product format
712050068
Labeler code
71205
Product ID
71205-068_0073dfe4-2772-4fc6-a391-504cd2c4a8fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
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
71205-068-20Methocarbamol20 in 1 BOTTLETABLET, COATED206
71205-068-30Methocarbamol30 in 1 BOTTLETABLET, COATED306
71205-068-40Methocarbamol40 in 1 BOTTLETABLET, COATED406
71205-068-45Methocarbamol45 in 1 BOTTLETABLET, COATED456
71205-068-60Methocarbamol60 in 1 BOTTLETABLET, COATED606
71205-068-90Methocarbamol90 in 1 BOTTLETABLET, COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-068-20EA - Each71205-068023f484b-0466-474a-aca4-c3a1271f4bde12018-10-11
71205-068-30EA - Each71205-068e5db4443-aa06-4935-ae1d-255b61c0643b12018-10-11
71205-068-40EA - Each71205-068958f9f2c-f513-4479-924e-e57e445c3cab12018-10-11
71205-068-45EA - Each71205-068f6c978ab-e01a-4a5b-9b7d-46927710138a12018-10-11
71205-068-60EA - Each71205-068c3d4c8ef-a123-4e8e-a592-58652099e43712018-10-11
71205-068-90EA - Each71205-0687f178d3e-2e5f-4695-97c4-e1f08550ca0312020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-068METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 6 package rows20220421_f6193255-0e83-4510-bc86-30c926ee8fd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSNf6193255-0e83-4510-bc86-30c926ee8fd16
197944methocarbamol 750 MG Oral TabletSCDf6193255-0e83-4510-bc86-30c926ee8fd16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-068-207120500682020 TABLET, COATED in 1 BOTTLE (71205-068-20) 2018-08-010000-00-00NoNoCurrent
71205-068-307120500683030 TABLET, COATED in 1 BOTTLE (71205-068-30) 2018-07-020000-00-00NoNoCurrent
71205-068-407120500684040 TABLET, COATED in 1 BOTTLE (71205-068-40) 2018-07-020000-00-00NoNoCurrent
71205-068-457120500684545 TABLET, COATED in 1 BOTTLE (71205-068-45) 2018-08-010000-00-00NoNoCurrent
71205-068-607120500686060 TABLET, COATED in 1 BOTTLE (71205-068-60) 2018-08-010000-00-00NoNoCurrent
71205-068-907120500689090 TABLET, COATED in 1 BOTTLE (71205-068-90) 2018-08-010000-00-00NoNoCurrent