Methocarbamol

Product NDC
76385-124
11-digit product format
763850124
Labeler code
76385
Product ID
76385-124_1739d3e9-4645-4a0e-bec4-727f8ec63c23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
UNICHEM PHARMACEUTICALS (USA), INC.
Application
ANDA208507
Marketing category
ANDA
Marketing start
2018-01-15
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208507-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2017-07-21
A208507-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2017-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208507-001AA
A208507-002AA

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-2184e616aacf4f…
2026-08-18 06:07:402026-07A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-2174a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208507-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A208507-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A208507-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A208507-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208507-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208507-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208507-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208507-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208507-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208507-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208507-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208507-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208507-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208507-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208507-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208507-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208507-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208507-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208507-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208507-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208507-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208507-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208507-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208507-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208507-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208507-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208507-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208507-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208507-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208507-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208507-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208507-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208507-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208507-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208507-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208507-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208507-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208507-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208507-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208507-002AA174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL750 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
5777cbb0-b5fd-4b36-ac1d-bc105fe96888Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76385-124-01Methocarbamol100 in 1 BOTTLETABLET, FILM COATED1005
76385-124-50Methocarbamol500 in 1 BOTTLETABLET, FILM COATED5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-124-01EA - Each76385-1242f46902d-3a4e-4d7a-8847-ce4a8dc3158112018-05-09
76385-124-50EA - Each76385-1248e33297d-6ec2-4b14-a013-34a55924852212018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-124METHOCARBAMOL TABLET, FILM COATED [BAYSHORE PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20240118_5777cbb0-b5fd-4b36-ac1d-bc105fe96888.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3212f121-9428-4186-8f00-accf08bca4732026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.288a3bcd-a2c8-4a9b-9602-59c0493b4a8d2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.3b0e60a7-3cff-4665-a473-ad3257619cdd2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.943fe701-5d7d-4abe-a529-c5a548e94bc62026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.440bf1ba-a704-4c35-bece-0a0987fc0c112026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.12c8da39-3a0e-4303-9655-29dd835078372026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLUNICHEM PHARMACEUTICALS (USA), INC.5777cbb0-b5fd-4b36-ac1d-bc105fe968882026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
ndc (product): 76385-124
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsff572473-90e3-4f3b-a40e-8b97b86d327b2025-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9357672f-5d4d-40f5-a304-e0c34e174dc32025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCc06c4a63-491c-baa2-e053-2a95a90a09ff2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCc9600cc9-7e27-6e19-e053-2995a90ab0242024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLAsclemed USA, Inc.c40d5c1d-9bd8-44aa-85a4-e1a34e1d36732022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLProficient Rx LP201205d1-22f2-46bb-b298-02d4978ba5682022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLProficient Rx LP39b4362e-a26e-49cb-9d06-898bc9b0e0052021-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLCd825e4d6-8b00-473a-a6e6-90f5c3ad5bec2018-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208507
application number: ANDA208507

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN440bf1ba-a704-4c35-bece-0a0987fc0c1115
197944methocarbamol 750 MG Oral TabletSCD440bf1ba-a704-4c35-bece-0a0987fc0c1115
197944methocarbamol 750 MG Oral TabletPSN3b0e60a7-3cff-4665-a473-ad3257619cdd14
197944methocarbamol 750 MG Oral TabletSCD3b0e60a7-3cff-4665-a473-ad3257619cdd14
197944methocarbamol 750 MG Oral TabletPSNc9600cc9-7e27-6e19-e053-2995a90ab0248
197944methocarbamol 750 MG Oral TabletSCDc9600cc9-7e27-6e19-e053-2995a90ab0248
197943methocarbamol 500 MG Oral TabletPSN3212f121-9428-4186-8f00-accf08bca4737
197944methocarbamol 750 MG Oral TabletPSN3212f121-9428-4186-8f00-accf08bca4737
197943methocarbamol 500 MG Oral TabletSCD3212f121-9428-4186-8f00-accf08bca4737
197944methocarbamol 750 MG Oral TabletSCD3212f121-9428-4186-8f00-accf08bca4737
197943methocarbamol 500 MG Oral TabletPSN5777cbb0-b5fd-4b36-ac1d-bc105fe968885
197944methocarbamol 750 MG Oral TabletPSN5777cbb0-b5fd-4b36-ac1d-bc105fe968885
197943methocarbamol 500 MG Oral TabletSCD5777cbb0-b5fd-4b36-ac1d-bc105fe968885
197944methocarbamol 750 MG Oral TabletSCD5777cbb0-b5fd-4b36-ac1d-bc105fe968885
197943methocarbamol 500 MG Oral TabletPSN01baa84f-453e-4954-bdf1-276ad7d484a14
197944methocarbamol 750 MG Oral TabletPSN01baa84f-453e-4954-bdf1-276ad7d484a14
197944methocarbamol 750 MG Oral TabletPSN201205d1-22f2-46bb-b298-02d4978ba5684
197943methocarbamol 500 MG Oral TabletSCD01baa84f-453e-4954-bdf1-276ad7d484a14
197944methocarbamol 750 MG Oral TabletSCD201205d1-22f2-46bb-b298-02d4978ba5684
197944methocarbamol 750 MG Oral TabletSCD01baa84f-453e-4954-bdf1-276ad7d484a14
197944methocarbamol 750 MG Oral TabletPSN89175a33-d4c7-c1ef-e053-2a95a90a0fb13
197944methocarbamol 750 MG Oral TabletSCD89175a33-d4c7-c1ef-e053-2a95a90a0fb13
197944methocarbamol 750 MG Oral TabletPSNc40d5c1d-9bd8-44aa-85a4-e1a34e1d36732
197944methocarbamol 750 MG Oral TabletSCDc40d5c1d-9bd8-44aa-85a4-e1a34e1d36732
197944methocarbamol 750 MG Oral TabletPSNb7685a89-1d10-f795-e053-2995a90af2be1
197944methocarbamol 750 MG Oral TabletPSNd825e4d6-8b00-473a-a6e6-90f5c3ad5bec1
197944methocarbamol 750 MG Oral TabletSCDb7685a89-1d10-f795-e053-2995a90af2be1
197944methocarbamol 750 MG Oral TabletSCDd825e4d6-8b00-473a-a6e6-90f5c3ad5bec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76385-124-0176385012401100 TABLET, FILM COATED in 1 BOTTLE (76385-124-01) 2018-01-150000-00-00NoNoCurrent
76385-124-5076385012450500 TABLET, FILM COATED in 1 BOTTLE (76385-124-50) 2018-01-150000-00-00NoNoCurrent