Methocarbamol

Product NDC
72789-021
11-digit product format
727890021
Labeler code
72789
Product ID
72789-021_4af30668-89af-69a1-e063-6394a90a38f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA208507
Marketing category
ANDA
Marketing start
2018-01-15
Substance
METHOCARBAMOL
Active strength
500 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 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
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 · 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 UTC2026-02A208507-001METHOCARBAMOL500MGTABLET / 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…
2022-03-09 01:35 UTC2022-03A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208507-001METHOCARBAMOL500MGTABLET / ORALAA2017-07-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A208507-002METHOCARBAMOL750MGTABLET / ORALAA2017-07-21782e0a99824c…

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 UTC2026-02A208507-001AA1011fe1cb6892…
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…
2022-03-09 01:35 UTC2022-03A208507-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208507-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208507-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A208507-002AA1782e0a99824c…

Additional Listing Data#

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

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
943fe701-5d7d-4abe-a529-c5a548e94bc6Available 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
72789-021-01Methocarbamol100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016
72789-021-60Methocarbamol60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6016
72789-021-82Methocarbamol500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50016
72789-021-90Methocarbamol90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9016
72789-021-93Methocarbamol180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18016
72789-021-94Methocarbamol270 in 1 BOTTLE, PLASTICTABLET, FILM COATED27016
72789-021-99Methocarbamol240 in 1 BOTTLE, PLASTICTABLET, FILM COATED24016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-021-01EA - Each72789-021a847298d-cc94-4292-9d8f-afc21ff4b9d612019-11-12
72789-021-60EA - Each72789-02146b1621a-f7da-4de2-bc1c-e18160fa767312023-10-16
72789-021-82EA - Each72789-021eae9dd32-b8f2-4e9c-8e20-9bd001c1eca512019-11-12
72789-021-90EA - Each72789-0219159b07e-4ecd-4d61-b819-810394a8bdda12023-08-08
72789-021-93EA - Each72789-021694c4ac1-9a68-41d5-9a73-901be4e58c4712023-10-16
72789-021-94EA - Each72789-0212367ee84-da9e-4fe7-9c9e-0b7af81ae33012023-10-16
72789-021-99EA - Each72789-02133c0066b-0c53-488a-872d-ee34448d287a12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-021METHOCARBAMOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 7 package rows20240417_943fe701-5d7d-4abe-a529-c5a548e94bc6.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
ndc (product): 72789-021
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
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
197943methocarbamol 500 MG Oral TabletPSN943fe701-5d7d-4abe-a529-c5a548e94bc616
197943methocarbamol 500 MG Oral TabletSCD943fe701-5d7d-4abe-a529-c5a548e94bc616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-021-0172789002101100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-01) 2019-10-240000-00-00NoNoCurrent
72789-021-607278900216060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-60) 2023-09-12NoNoCurrent
72789-021-8272789002182500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-82) 2019-10-240000-00-00NoNoCurrent
72789-021-907278900219090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-90) 2023-09-12NoNoCurrent
72789-021-9372789002193180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-93) 2019-10-24NoNoCurrent
72789-021-9472789002194270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-94) 2019-10-24NoNoCurrent
72789-021-9972789002199240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-99) 2019-10-24NoNoCurrent