Methocarbamol

Product NDC
50436-9910
11-digit product format
504369910
Labeler code
50436
Product ID
50436-9910_b98c85ff-819e-4e63-b29f-23ded75574c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA040489
Marketing category
ANDA
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50436-9910IInactivated by FDA2026-08-03
excluded packagepackage50436-991050436-9910-1IInactivated by FDA2026-08-03
excluded packagepackage50436-991050436-9910-2IInactivated by FDA2026-08-03
excluded packagepackage50436-991050436-9910-3IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040489-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2003-01-29
A040489-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2003-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040489-001AA
A040489-002AA

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.

Product history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-295aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-298869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-293f01610625f2…
2019-12-14 00:12 UTC2019-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-293f01610625f2…
2019-09-15 20:21 UTC2019-09A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29b00525d2431f…
2019-09-15 20:21 UTC2019-09A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29ea99ee380514…
2019-07-19 19:46 UTC2019-07A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-296a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-291c564ffb4f44…
2024-02-18 07:12 UTC2024-02A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29a72a2bbeb626…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040489-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040489-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040489-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040489-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040489-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040489-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040489-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040489-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040489-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040489-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040489-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040489-002AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040489-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040489-002AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040489-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040489-002AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040489-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040489-002AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040489-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040489-002AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040489-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A040489-002AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040489-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040489-002AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040489-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040489-002AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040489-001AA16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040489-002AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040489-001AA11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A040489-002AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040489-001AA1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A040489-002AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040489-001AA1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040489-002AA1a72a2bbeb626…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.3d4a2486-863e-4e9f-be3b-67882863e7d42026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.6b9ed3a4-46d5-462e-ac93-6b959b314d772026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.adb49cb7-8900-44dc-add0-22e2cd8235ac2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.0deb5368-ffdc-40fc-a97c-ba89b7a97e502026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9617e2b0-4255-4542-95ca-9ee1818ca4502026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLHAWAII REPACK, INC.8643032a-c491-4ae4-ac46-5e0c4c79dc5b2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutionscfdc0d68-00ad-44d6-b932-819cc3d5d60e2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsb81a8e64-ae41-409b-94a6-b36cb50bc25d2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLHAWAII REPACK, INC.c4744824-4c74-411d-aa8e-c63ee9d899132026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.4ef1c2c0-31e1-4f85-b645-ff47a057a9942026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals, Inc425abc3b-2111-4fac-bf27-b685d1e657af2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLDirect_rx4c5c8933-a4b5-f9c2-e063-6294a90a6f002026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack5af36a83-2b36-4fe2-8c6a-61b5516214212026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackcc004f5c-d5fc-48c5-9f37-c59b9c37e1132026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack9076b4ad-17be-4933-a975-7bf80cc92b492026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f8aed5d-ba8d-4c32-872b-08ab15240cc12026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLSt. Mary's Medical Park Pharmacyfd8cac57-9664-1fa0-e053-6294a90af8722026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack6466438c-4609-4554-8919-35710a1b556d2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack33f89a57-f65d-4e99-a3a3-690ef805d8692026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack6af87b4e-6507-4190-b043-a6d3b440314a2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-9910-12023-01-30C16284748780-1f386c649-eefb-0266-e053-dadaa90a7c1aMethocarbamol Tablets 500mg
50436-9910-22023-01-30C16284748780-1f386c649-eefb-0266-e053-dadaa90a7c1aMethocarbamol Tablets 500mg
50436-9910-32023-01-30C16284748780-1f386c649-eefb-0266-e053-dadaa90a7c1aMethocarbamol Tablets 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-9910-1Methocarbamol30 in 1 BOTTLETABLET302
50436-9910-2Methocarbamol60 in 1 BOTTLETABLET602
50436-9910-3Methocarbamol90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-9910-1EA - Each50436-99104232655a-f54f-4066-8b91-624b0df6f1f412021-12-08
50436-9910-2EA - Each50436-9910e3b6a36a-cdaa-47ee-8265-b633ad96555912021-12-08
50436-9910-3EA - Each50436-9910050d46e6-23c2-47dd-bcfd-7d75a3463e8312021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-9910METHOCARBAMOL TABLET [UNIT DOSE SERVICES]2Legacy NDC, 3 package rows20211023_b77876dd-1be7-482c-b125-d1879b41795b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSNb77876dd-1be7-482c-b125-d1879b41795b2
197943methocarbamol 500 MG Oral TabletSCDb77876dd-1be7-482c-b125-d1879b41795b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50436-9910-15043699100130 TABLET in 1 BOTTLE (50436-9910-1) 30 tablet2021-10-120000-00-00NoNoCurrent
50436-9910-25043699100260 TABLET in 1 BOTTLE (50436-9910-2) 60 tablet2021-10-120000-00-00NoNoCurrent
50436-9910-35043699100390 TABLET in 1 BOTTLE (50436-9910-3) 90 tablet2021-10-120000-00-00NoNoCurrent