Methocarbamol

Product NDC
72789-429
11-digit product format
727890429
Labeler code
72789
Product ID
72789-429_57c4a729-8ece-4c86-e063-6394a90a8787
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040489
Marketing category
ANDA
Marketing start
2019-08-15
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
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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2984e616aacf4f…
2026-09-14 22:38:342026-08A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2984e616aacf4f…
2026-08-18 06:07:402026-07A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2979d66fd596c7…
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…

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 22:38:342026-08A040489-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A040489-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A040489-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040489-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040489-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040489-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040489-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040489-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040489-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040489-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-002AA179d66fd596c7…
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…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
adb49cb7-8900-44dc-add0-22e2cd8235acAvailable 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
72789-429-20Methocarbamol20 in 1 BOTTLE, PLASTICTABLET208
72789-429-30Methocarbamol30 in 1 BOTTLE, PLASTICTABLET308
72789-429-40Methocarbamol40 in 1 BOTTLE, PLASTICTABLET408
72789-429-60Methocarbamol60 in 1 BOTTLE, PLASTICTABLET608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-429-20EA - Each72789-4292eeccae3-d79f-497d-87dd-61e817b6e43312025-06-13
72789-429-30EA - Each72789-429eb158e7c-805e-4182-8198-e7ec5367fa3712024-11-05
72789-429-40EA - Each72789-429066f7474-eb0f-4b69-879f-e2fafe4957dd12025-02-10
72789-429-60EA - Each72789-4296c8084c2-9424-4aa9-8590-973290f6c50412024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-429METHOCARBAMOL TABLET [PD-RX PHARMACEUTICALS, INC.]8Current NDC, 4 package rows20250427_adb49cb7-8900-44dc-add0-22e2cd8235ac.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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLDoc Rxf4956165-3605-4ff3-9fd1-70157edc08ca2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLOxford Pharmaceuticals, LLC06dc72a6-ef3a-425a-9194-a9d228093cc42026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackb72a3fff-9710-4c60-8ca6-ed428377fc242026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackd3448618-c9b4-4cb9-a30e-1afc8197cfe12026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLASCLEMED USA INC.077fa923-bee0-4b34-a52d-6f870bcb48282026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLProficient Rx LP311c79a5-1447-4fef-8726-ae003ef64db52026-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLAdvanced Rx of Tennessee, LLC4b1d8ac6-d25d-1c37-e063-6394a90aba292026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPHOENIX RX LLC4abc29e9-a0cc-06cf-e063-6294a90ad8742026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLProficient Rx LPe4ebe9cf-a274-47c7-b740-4b3d6e9dc52b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPHOENIX RX LLC39bc9ecf-837e-5bb8-e063-6394a90a917e2025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLDoc Rx5e55526f-bb34-4b67-85ea-b2765e8066bb2025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLGENTEX PHARMA, LLC35c044a6-90c0-55f8-e063-6294a90aad482025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLAdvanced Rx of Tennessee, LLC2cf76cdc-820d-1c5b-e063-6294a90a35aa2025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLRedpharm Drug, Inc.09d22ef9-a472-4db9-e063-6394a90a88702025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
METHOCARBAMOLMETHOCARBAMOLDirectRxceb428e0-d6e4-57b7-e053-2995a90afcda2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLAdvanced Rx of Tennessee, LLCafc9d84d-c8dd-05c0-e053-2a95a90a22a22024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCf6567e04-12f0-fa79-e053-2995a90a9a0e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack8c18ffef-b2c5-4af2-af66-e22c168e76802024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLKey Therapeuticsa88a6c84-b55a-4b6b-ac01-554079f6e3042024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLKey Therapeuticscf931001-95bd-4900-98d5-f5ef54b49d992024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSNadb49cb7-8900-44dc-add0-22e2cd8235ac8
197944methocarbamol 750 MG Oral TabletSCDadb49cb7-8900-44dc-add0-22e2cd8235ac8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-429-207278904292020 TABLET in 1 BOTTLE, PLASTIC (72789-429-20) 20 tablet2025-04-25NoNoCurrent
72789-429-307278904293030 TABLET in 1 BOTTLE, PLASTIC (72789-429-30) 30 tablet2025-09-12NoNoCurrent
72789-429-407278904294040 TABLET in 1 BOTTLE, PLASTIC (72789-429-40) 40 tablet2024-12-23NoNoCurrent
72789-429-607278904296060 TABLET in 1 BOTTLE, PLASTIC (72789-429-60) 60 tablet2024-11-12NoNoCurrent