Methocarbamol

Product NDC
71205-375
11-digit product format
712050375
Labeler code
71205
Product ID
71205-375_0d89910b-e14d-43cb-b669-8f6789efc781
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA086989
Marketing category
ANDA
Marketing start
2017-12-15
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

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982ea99ee380514…
2022-10-28 04:53 UTC2022-10A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086989-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A086989-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A086989-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A086989-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A086989-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A086989-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A086989-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A086989-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A086989-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A086989-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A086989-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A086989-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A086989-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A086989-001AA1ea99ee380514…
2022-10-28 04:53 UTC2022-10A086989-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086989-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086989-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
125OD7737XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197943Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
75b964b7-3e76-4460-9777-7656b5daa32eAvailable on FDA.report

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
71205-375-20Methocarbamol20 in 1 BOTTLETABLET202
71205-375-30Methocarbamol30 in 1 BOTTLETABLET302
71205-375-60Methocarbamol60 in 1 BOTTLETABLET602
71205-375-90Methocarbamol90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-375-20EA - Each71205-375a82f0160-c8ff-4942-857d-58486f4425ac12021-02-05
71205-375-30EA - Each71205-37548302bd8-816b-46ff-aa56-87eef9b7cc8112020-03-10
71205-375-90EA - Each71205-375b0451a78-e3e7-4baa-b411-88c87ba4b46812020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-375METHOCARBAMOL TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 4 package rows20201205_75b964b7-3e76-4460-9777-7656b5daa32e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack43ea5baa-4200-47ff-8819-44c802cba9772025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086989
application number: ANDA086989
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack8cf27774-82ed-4ed1-a55d-41bf476745db2024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086989
application number: ANDA086989
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackf1bce76f-4c3a-40d2-8107-afc0d3a6ba192023-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086989
application number: ANDA086989
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC27c39343-44e0-4ca6-a67f-1e6d11dd67992021-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086989
application number: ANDA086989
MethocarbamolMETHOCARBAMOLProficient Rx LP75b964b7-3e76-4460-9777-7656b5daa32e2020-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 086989
application number: ANDA086989
ndc (product): 71205-375

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN75b964b7-3e76-4460-9777-7656b5daa32e2
197943methocarbamol 500 MG Oral TabletSCD75b964b7-3e76-4460-9777-7656b5daa32e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-375-207120503752020 TABLET in 1 BOTTLE (71205-375-20) 20 tablet2020-12-030000-00-00NoNoCurrent
71205-375-307120503753030 TABLET in 1 BOTTLE (71205-375-30) 30 tablet2019-12-200000-00-00NoNoCurrent
71205-375-607120503756060 TABLET in 1 BOTTLE (71205-375-60) 60 tablet2019-12-200000-00-00NoNoCurrent
71205-375-907120503759090 TABLET in 1 BOTTLE (71205-375-90) 90 tablet2019-12-200000-00-00NoNoCurrent