Methocarbamol

Product NDC
52959-167
11-digit product format
529590167
Labeler code
52959
Product ID
52959-167_70dca5f7-12fd-4c32-860c-d814f646c769
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA084277
Marketing category
ANDA
Marketing start
1987-11-01
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
500 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 · 13 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-167IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-00IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-03IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-10IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-12IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-15IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-20IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-21IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-24IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-30IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-40IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-60IInactivated by FDA2026-10-15
excluded packagepackage52959-16752959-167-90IInactivated by FDA2026-10-15

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 5 · 286 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 packagepackage52959-167-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-24d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-167-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-24f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-167-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-242ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-167-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-24a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-167-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-167-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-167-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-167-24cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-167-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-167-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-167-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-167-00cfe11265f3b6…090c488252e2…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A084277-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / 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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982c2088c7a36db…
2026-09-14 22:38:342026-08A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084277-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084277-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A084277-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A084277-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084277-001METHOCARBAMOL500MGTABLET / ORALApproved before 19823a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A084277-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A084277-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A084277-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A084277-001AA1ea99ee380514…

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
52959-167-00Methocarbamol100 in 1 BOTTLETABLET1002
52959-167-03Methocarbamol120 in 1 BOTTLETABLET1202
52959-167-10Methocarbamol10 in 1 BOTTLETABLET102
52959-167-12Methocarbamol12 in 1 BOTTLETABLET122
52959-167-15Methocarbamol15 in 1 BOTTLETABLET152
52959-167-20Methocarbamol20 in 1 BOTTLETABLET202
52959-167-21Methocarbamol21 in 1 BOTTLETABLET212
52959-167-24Methocarbamol24 in 1 BOTTLETABLET242
52959-167-30Methocarbamol30 in 1 BOTTLETABLET302
52959-167-40Methocarbamol40 in 1 BOTTLETABLET402
52959-167-60Methocarbamol60 in 1 BOTTLETABLET602
52959-167-90Methocarbamol90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-167-00EA - Each52959-1671e01e903-c887-489d-94ff-5b71f177365c12012-07-24
52959-167-03EA - Each52959-16750ab25ff-cae7-4166-8164-e5f47ddebc1512012-07-24
52959-167-10EA - Each52959-167b19d0b33-e463-4f37-9ba2-a9490905303b12012-07-24
52959-167-12EA - Each52959-167cef2c738-4fa1-42fb-ad07-5b41edfaa33a12012-07-24
52959-167-15EA - Each52959-1679291a3b3-0142-456e-bbae-6e839919053212012-07-24
52959-167-20EA - Each52959-167344af889-43bc-4a20-94f5-718f7c0d68a212012-07-24
52959-167-21EA - Each52959-1676d524322-7d05-42cb-a2c4-3ada32d5390f12012-07-24
52959-167-24EA - Each52959-167194cdad3-5fb9-43aa-b682-dfeff92bb80612012-07-24
52959-167-30EA - Each52959-167ab807958-bc36-4669-91c5-d83c9a7dd2d312012-07-24
52959-167-40EA - Each52959-167125d5c27-c519-4a18-8823-6e8970e41e3912012-07-24
52959-167-60EA - Each52959-1671e965b97-930b-4f59-a29a-8ab97fd1dca412012-07-24
52959-167-90EA - Each52959-167325d98a3-4b09-4efa-8136-9421bb9b8c8d12012-07-24

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
52959-167METHOCARBAMOL TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 12 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
52959-167-0052959016700100 in 1 BOTTLEHistorical
52959-167-0352959016703120 in 1 BOTTLEHistorical
52959-167-105295901671010 in 1 BOTTLEHistorical
52959-167-125295901671212 in 1 BOTTLEHistorical
52959-167-155295901671515 in 1 BOTTLEHistorical
52959-167-205295901672020 in 1 BOTTLEHistorical
52959-167-215295901672121 in 1 BOTTLEHistorical
52959-167-245295901672424 in 1 BOTTLEHistorical
52959-167-305295901673030 in 1 BOTTLEHistorical
52959-167-405295901674040 in 1 BOTTLEHistorical
52959-167-605295901676060 in 1 BOTTLEHistorical
52959-167-905295901679090 in 1 BOTTLEHistorical