Methocarbamol

Product NDC
61919-610
Requested package NDC
61919-610-60
11-digit product format
619190610
Labeler code
61919
Product ID
61919-610_ea4ea482-a7f7-d4a0-e053-2995a90a5689
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209312
Marketing category
ANDA
Marketing start
2019-08-27
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-61061919-610-60IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A209312-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAARS2018-05-07
A209312-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAARS2018-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209312-001AA
A209312-002AA

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209312-002METHOCARBAMOL750MGTABLET / ORALAA2018-05-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209312-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209312-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209312-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209312-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209312-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209312-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209312-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209312-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209312-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209312-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209312-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209312-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209312-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209312-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209312-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209312-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209312-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209312-002AA1782e0a99824c…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-610-60Methocarbamol60 in 1 BOTTLETABLET, COATED604
61919-610-30Methocarbamol30 in 1 BOTTLETABLET, COATED302
61919-610-40Methocarbamol40 in 1 BOTTLETABLET, COATED402
61919-610-90Methocarbamol90 in 1 BOTTLETABLET, COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-610-30EA - Each61919-6104d7dcd54-9181-43b0-a540-df32fde72f9d12019-09-05
61919-610-40EA - Each61919-6100a034f36-4377-4466-808d-8b6c4e16254312019-09-05
61919-610-60EA - Each61919-610653ccadc-ba94-48da-b2f8-0f93a056c63a12019-05-02
61919-610-90EA - Each61919-610a1b60f03-73ce-4d6e-86be-65b86e682f8612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-610METHOCARBAMOL TABLET, FILM COATED METHOCARBAMOL TABLET, COATED METHOCARBAMOL TABLET [DIRECTRX]4Legacy NDC, 1 package rows20190424_270b68a6-1469-190d-e054-00144ff8d46c.zip
61919-610METHOCARBAMOL TABLET, COATED [DIRECT_RX]2Legacy NDC, 1 package rows20221007_911f63c2-a6a1-98e9-e053-2995a90a5bb1.zip
61919-610METHOCARBAMOL TABLET, COATED [DIRECT_RX]2Legacy NDC, 1 package rows20221007_911f8c7a-0a84-7ed8-e053-2995a90a177f.zip
61919-610METHOCARBAMOL TABLET, COATED [DIRECT_RX]2Legacy NDC, 1 package rows20221007_911f1367-bc7c-f752-e053-2a95a90a212b.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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.52b20439-6bf4-435e-817a-c3b3fc70846a2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.37767123-8b72-4e1f-b00d-ff3305e9923f2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSUnit Dose Solutions, Inc.561ae476-9e1f-038a-e063-6394a90aa5c72026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSGranules Pharmaceuticals Inc.6f0d3966-962d-fa7c-e053-2a91aa0a8e3c2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSBryant Ranch Prepack65c460f6-6470-41ff-abb4-d9d54ecc52f72026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSSt. Mary's Medical Park Pharmacy7d4dd78a-f902-6ff2-e053-2991aa0ac7d72026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSPreferred Pharmaceuticals Inc.43f83b87-e169-46fe-98bd-6af373595bd32026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSPreferred Pharmaceuticals Inc.e03878d3-d780-4e7f-b828-20ac2a1099332026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSCoupler LLC52b87514-e6e0-ab57-e063-6394a90a6b232026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNuCare Pharmaceuticals,Inc.71c21226-cd96-33ed-e053-2995a90a52692026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSSt. Mary's Medical Park Pharmacyfaa81ad3-2bd2-d637-e053-6294a90a2d362026-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSProficient Rx LP23163bc1-dec7-41f6-baed-eedebfd6be7e2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.1dc3a5b1-c83b-406b-a59d-ce8075e4ccf92026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSAdvanced Rx of Tennessee, LLC4de118fe-bd8e-6cc4-e063-6394a90a13202026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSAdvanced Rx of Tennessee, LLC4cefe51c-d824-a862-e063-6394a90a77172026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSRedpharm Drug44f264fd-bf40-bed9-e063-6294a90ac44a2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNuCare Pharmaceuticals,Inc.72f36d28-15d2-30f6-e053-2a91aa0ad1ce2026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNorthwind Health Company, LLCf2b4ed95-0469-393a-e053-2a95a90a98ed2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
METHOCARBAMOLMETHOCARBAMOLDIRECT RX31508051-c9cb-149b-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNorthwind Health Company, LLCf2b4ed5f-3489-9ee4-e053-2995a90a25f02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN270b68a6-1469-190d-e054-00144ff8d46c4
197944methocarbamol 750 MG Oral TabletPSN270b68a6-1469-190d-e054-00144ff8d46c4
197943methocarbamol 500 MG Oral TabletSCD270b68a6-1469-190d-e054-00144ff8d46c4
197944methocarbamol 750 MG Oral TabletSCD270b68a6-1469-190d-e054-00144ff8d46c4
197943methocarbamol 500 MG Oral TabletPSN911f1367-bc7c-f752-e053-2a95a90a212b2
197943methocarbamol 500 MG Oral TabletPSN911f63c2-a6a1-98e9-e053-2995a90a5bb12
197943methocarbamol 500 MG Oral TabletPSN911f8c7a-0a84-7ed8-e053-2995a90a177f2
197943methocarbamol 500 MG Oral TabletSCD911f1367-bc7c-f752-e053-2a95a90a212b2
197943methocarbamol 500 MG Oral TabletSCD911f63c2-a6a1-98e9-e053-2995a90a5bb12
197943methocarbamol 500 MG Oral TabletSCD911f8c7a-0a84-7ed8-e053-2995a90a177f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-610-606191906106060 TABLET, COATED in 1 BOTTLE (61919-610-60) 2019-04-180000-00-00NoNoCurrent