Methocarbamol

Product NDC
52959-099
11-digit product format
529590099
Labeler code
52959
Product ID
52959-099_70dca5f7-12fd-4c32-860c-d814f646c769
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA084276
Marketing category
ANDA
Marketing start
1987-11-01
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 14 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-099IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-00IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-03IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-10IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-15IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-20IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-21IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-28IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-30IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-40IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-45IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-50IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-60IInactivated by FDA2026-10-05
excluded packagepackage52959-09952959-099-90IInactivated by FDA2026-10-05

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 6 · 308 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-099-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-099-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-452ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-099-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-45a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-099-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-099-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-099-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-099-03cfe11265f3b6…090c488252e2…

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084276-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALApproved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084276-002METHOCARBAMOL750MGTABLET / ORALAAApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084276-002METHOCARBAMOL750MGTABLET / ORALAAApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A084276-002METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A084276-002METHOCARBAMOL750MGTABLET / ORALAAApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084276-002METHOCARBAMOL750MGTABLET / ORALApproved before 1982f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A084276-002AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A084276-002AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A084276-002AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A084276-002AA1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

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
52959-099-00Methocarbamol100 in 1 BOTTLETABLET1002
52959-099-03Methocarbamol120 in 1 BOTTLETABLET1202
52959-099-10Methocarbamol10 in 1 BOTTLETABLET102
52959-099-15Methocarbamol15 in 1 BOTTLETABLET152
52959-099-20Methocarbamol20 in 1 BOTTLETABLET202
52959-099-21Methocarbamol21 in 1 BOTTLETABLET212
52959-099-28Methocarbamol28 in 1 BOTTLETABLET282
52959-099-30Methocarbamol30 in 1 BOTTLETABLET302
52959-099-40Methocarbamol40 in 1 BOTTLETABLET402
52959-099-45Methocarbamol45 in 1 BOTTLETABLET452
52959-099-50Methocarbamol50 in 1 BOTTLETABLET502
52959-099-60Methocarbamol60 in 1 BOTTLETABLET602
52959-099-90Methocarbamol90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-099-00EA - Each52959-099c372fe2a-2fc3-4050-a20a-3ef979f5be1f12012-07-24
52959-099-03EA - Each52959-0993283ff9e-9b72-471e-9183-aeab7861937b12012-07-24
52959-099-10EA - Each52959-099a5090ce6-995e-480f-8bf9-279c01b227fe12012-07-24
52959-099-15EA - Each52959-0996ca64458-07df-462e-b7d8-c0d86089f65512012-07-24
52959-099-20EA - Each52959-0993bdafa1c-557c-4603-a486-950ac1e24c7012012-07-24
52959-099-21EA - Each52959-09943d06b2d-1915-4beb-a1d9-c508e640cfa012012-07-24
52959-099-28EA - Each52959-09906a38325-5a90-4ebf-a628-0d97ed8e8b6e12012-07-24
52959-099-30EA - Each52959-0996887c6cc-fbd3-4fa4-8c0e-dd1ad2c2b50312012-07-24
52959-099-40EA - Each52959-0999f5ec11a-4efb-4d11-9c56-5dc3f55d9f0e12012-07-24
52959-099-45EA - Each52959-099b19df53c-148a-4060-8272-a7ab9baee86412012-07-24
52959-099-50EA - Each52959-099f5150ca5-ba1a-4c4e-a54f-9a11653b162a12012-07-24
52959-099-60EA - Each52959-09922c9b6dc-263f-4f13-8b0a-fc42a013ab4e12012-07-24
52959-099-90EA - Each52959-099582e4288-a401-4a0c-8dfa-72cb8d688c0312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XMETHOCARBAMOL TABLET [H.J. HARKINS COMPANY, INC.]2
METHOCARBAMOLACTIVE MOIETY125OD7737XMETHOCARBAMOL TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-099METHOCARBAMOL TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 13 package rows20111221_9811b723-5fe4-4459-a209-7e3645774338.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN9811b723-5fe4-4459-a209-7e36457743382
197944methocarbamol 750 MG Oral TabletPSN9811b723-5fe4-4459-a209-7e36457743382
197943methocarbamol 500 MG Oral TabletSCD9811b723-5fe4-4459-a209-7e36457743382
197944methocarbamol 750 MG Oral TabletSCD9811b723-5fe4-4459-a209-7e36457743382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-099-0052959009900100 in 1 BOTTLEHistorical
52959-099-0352959009903120 in 1 BOTTLEHistorical
52959-099-105295900991010 in 1 BOTTLEHistorical
52959-099-155295900991515 in 1 BOTTLEHistorical
52959-099-205295900992020 in 1 BOTTLEHistorical
52959-099-215295900992121 in 1 BOTTLEHistorical
52959-099-285295900992828 in 1 BOTTLEHistorical
52959-099-305295900993030 in 1 BOTTLEHistorical
52959-099-405295900994040 in 1 BOTTLEHistorical
52959-099-455295900994545 in 1 BOTTLEHistorical
52959-099-505295900995050 in 1 BOTTLEHistorical
52959-099-605295900996060 in 1 BOTTLEHistorical
52959-099-905295900999090 in 1 BOTTLEHistorical