Methocarbamol

Product NDC
21695-078
11-digit product format
216950078
Labeler code
21695
Product ID
21695-078_2e5d447c-a50c-4905-b56f-32fe86824dd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA085159
Marketing category
ANDA
Marketing start
2000-01-01
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-078IInactivated by FDA2026-08-10
excluded packagepackage21695-07821695-078-07IInactivated by FDA2026-08-10
excluded packagepackage21695-07821695-078-14IInactivated by FDA2026-08-10
excluded packagepackage21695-07821695-078-20IInactivated by FDA2026-08-10
excluded packagepackage21695-07821695-078-30IInactivated by FDA2026-08-10
excluded packagepackage21695-07821695-078-40IInactivated by FDA2026-08-10
excluded packagepackage21695-07821695-078-60IInactivated by FDA2026-08-10

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 3 · 154 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 packagepackage21695-078-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-078-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-078-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-078-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-078-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-078-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-078-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-078-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-078-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-078-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-078-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-078-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-078-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-078-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-078-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-078-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-078-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-078-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-078-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-078-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-078-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-078-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-078-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-078-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-078-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-078-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-078-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-078-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-078-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-078-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-078-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-078-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-078-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-078-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-078-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-078-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-078-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-078-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-078-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-078-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-078-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-078-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-078-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-078-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-078-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-078-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-078-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-078-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-078-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-078-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-078-200efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085159-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085159-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A085159-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A085159-001METHOCARBAMOL500MGTABLET / ORALAAApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085159-001METHOCARBAMOL500MGTABLET / ORALApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A085159-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A085159-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A085159-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085159-001AA1ea99ee380514…

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
21695-078-07Methocarbamol7 in 1 BOTTLETABLET73
21695-078-14Methocarbamol14 in 1 BOTTLETABLET143
21695-078-20Methocarbamol20 in 1 BOTTLETABLET203
21695-078-30Methocarbamol30 in 1 BOTTLETABLET303
21695-078-40Methocarbamol40 in 1 BOTTLETABLET403
21695-078-60Methocarbamol60 in 1 BOTTLETABLET603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-078-07EA - Each21695-07811abd0a4-d903-4781-bdd4-9836bc45831312012-07-24
21695-078-14EA - Each21695-07890b8aefb-f014-4e64-ac98-d6095b9e11a212012-07-24
21695-078-20EA - Each21695-0784cc21192-bb11-421e-8aee-ac3af651e50112012-07-24
21695-078-30EA - Each21695-078c36e4d75-c459-41ec-bc0c-7cc9700bd25612012-07-24
21695-078-40EA - Each21695-0785bd89e21-541e-48a9-afd6-e5fecdf3f95812012-07-24
21695-078-60EA - Each21695-0782a584995-7626-4e4d-a2ac-eef9abd29ceb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XMETHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
METHOCARBAMOLACTIVE MOIETY125OD7737XMETHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
METHYLCELLULOSE (100 CPS)INACTIVE INGREDIENT4GFU244C4JMETHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-078METHOCARBAMOL TABLET [REBEL DISTRIBUTORS CORP.]3Legacy NDC, 6 package rows20110721_41a6a652-046e-4780-9c6b-000363def056.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN41a6a652-046e-4780-9c6b-000363def0563
197944methocarbamol 750 MG Oral TabletPSN41a6a652-046e-4780-9c6b-000363def0563
197943methocarbamol 500 MG Oral TabletSCD41a6a652-046e-4780-9c6b-000363def0563
197944methocarbamol 750 MG Oral TabletSCD41a6a652-046e-4780-9c6b-000363def0563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-078-07216950078077 in 1 BOTTLEHistorical
21695-078-142169500781414 in 1 BOTTLEHistorical
21695-078-202169500782020 in 1 BOTTLEHistorical
21695-078-302169500783030 in 1 BOTTLEHistorical
21695-078-402169500784040 in 1 BOTTLEHistorical
21695-078-602169500786060 in 1 BOTTLEHistorical