Methocarbamol Tablets, USP, 500 mg

Product NDC
63561-0173
11-digit product format
635610173
Labeler code
63561
Product ID
63561-0173_35c0e9af-ba8b-0416-e063-6294a90a87f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Granulation Technology, Inc.
Application
ANDA212623
Marketing category
ANDA
Marketing start
2025-06-10
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

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, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63561-0173-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63561-0173-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63561-0173-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63561-0173-5ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63561-0173-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63561-0173-50efc9e666f02…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
A212623-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2021-04-30
A212623-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2021-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212623-001AA
A212623-002AA

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 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-304b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-30782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212623-001METHOCARBAMOL500MGTABLET / ORALAA2021-04-306a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212623-002METHOCARBAMOL750MGTABLET / ORALAA2021-04-306a51e52b5d6a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212623-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212623-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212623-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212623-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212623-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212623-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212623-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212623-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212623-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212623-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212623-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212623-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212623-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212623-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212623-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212623-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212623-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212623-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212623-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212623-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212623-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212623-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212623-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212623-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212623-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212623-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212623-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A212623-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212623-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212623-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212623-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212623-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212623-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212623-002AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212623-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212623-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212623-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A212623-002AA1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212623-001AA16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212623-002AA16a51e52b5d6a…

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol Tablets, USP, 500 mg
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197943Internal RxNorm lookup
197944Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
70c5342c-9597-4fe6-863c-f8ae4adc063aAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0173-1Methocarbamol Tablets, USP, 500 mg100 in 1 BOTTLETABLET, FILM COATED1003
63561-0173-5Methocarbamol Tablets, USP, 500 mg500 in 1 BOTTLETABLET, FILM COATED5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63561-0173-1EA - Each63561-017376bdd0f0-632b-40f3-b5cd-2ecc6a26c38512025-07-08
63561-0173-5EA - Each63561-0173fb8ff3aa-2870-4bf5-9bea-c1497dd022ae12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63561-0173METHOCARBAMOL TABLETS, USP, 500 MG (METHOCARBAMOL) TABLET, FILM COATED METHOCARBAMOL TABLETS, USP, 750 MG (METHOCARBAMOL) TABLET, FILM COATED [GRANULATION TECHNOLOGY, INC.]2Current NDC, 2 package rows20250210_70c5342c-9597-4fe6-863c-f8ae4adc063a.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLMedcore LLC1a6b7327-fd42-4de0-bd0d-2dd478502d522026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212623
application number: ANDA212623
Methocarbamol Tablets, USP, 750 mgMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.60ebbdc4-7b0d-4ad4-a7ff-d99e9a1cb33c2026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212623
application number: ANDA212623
Methocarbamol Tablets, USP, 500 mgMETHOCARBAMOLMarlex Pharmaceuticals, Inc.d2e38ac9-1cf3-14ca-e053-2a95a90a85222025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212623
application number: ANDA212623
Methocarbamol Tablets, USP, 500 mgMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.6ca768bf-5095-4148-82d2-a0c2dec16d872025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212623
application number: ANDA212623
Methocarbamol Tablets, USP, 500 mgMETHOCARBAMOLBryant Ranch Prepackdfb0e2ee-fd87-4100-9d44-f7a091e73a6c2025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212623
application number: ANDA212623
Methocarbamol Tablets, USP, 500 mgMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.6500c6eb-fa1e-46a5-839f-13047e107e972025-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212623
application number: ANDA212623
Methocarbamol Tablets, USP, 500 mgMETHOCARBAMOLGranulation Technology, Inc.70c5342c-9597-4fe6-863c-f8ae4adc063a2025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212623
application number: ANDA212623
ndc (product): 63561-0173
Methocarbamol Tablets, USP, 750 mgMETHOCARBAMOLBryant Ranch Prepack3d686023-a4a2-4dae-8bfb-1f6b01ca24f02025-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212623
application number: ANDA212623

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN6ca768bf-5095-4148-82d2-a0c2dec16d878
197943methocarbamol 500 MG Oral TabletSCD6ca768bf-5095-4148-82d2-a0c2dec16d878
197943methocarbamol 500 MG Oral TabletPSN6500c6eb-fa1e-46a5-839f-13047e107e974
197943methocarbamol 500 MG Oral TabletSCD6500c6eb-fa1e-46a5-839f-13047e107e974
197943methocarbamol 500 MG Oral TabletPSN70c5342c-9597-4fe6-863c-f8ae4adc063a3
197944methocarbamol 750 MG Oral TabletPSN70c5342c-9597-4fe6-863c-f8ae4adc063a3
197943methocarbamol 500 MG Oral TabletSCD70c5342c-9597-4fe6-863c-f8ae4adc063a3
197944methocarbamol 750 MG Oral TabletSCD70c5342c-9597-4fe6-863c-f8ae4adc063a3
197943methocarbamol 500 MG Oral TabletPSNdfb0e2ee-fd87-4100-9d44-f7a091e73a6c2
197943methocarbamol 500 MG Oral TabletSCDdfb0e2ee-fd87-4100-9d44-f7a091e73a6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63561-0173-163561017301100 TABLET, FILM COATED in 1 BOTTLE (63561-0173-1) 2025-06-10NoNoCurrent
63561-0173-563561017305500 TABLET, FILM COATED in 1 BOTTLE (63561-0173-5) 2025-06-10NoNoCurrent