Methocarbamol

Product NDC
50436-0123
Requested package NDC
50436-0123-3
11-digit product format
504360123
Labeler code
50436
Product ID
50436-0123_4e9524e3-43c0-49ef-a503-b116f84fbff1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA208507
Marketing category
ANDA
Marketing start
2018-01-15
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
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50436-012350436-0123-3IInactivated by FDA2026-08-11

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 1 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

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
50436-0123-1Methocarbamol30 in 1 BOTTLETABLET, FILM COATED302
50436-0123-2Methocarbamol60 in 1 BOTTLETABLET, FILM COATED602
50436-0123-3Methocarbamol90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0123-1EA - Each50436-012377080d8a-b3b9-438b-aa3b-ed96a21b568c12021-09-07
50436-0123-2EA - Each50436-0123f3360047-76e2-45e2-8b96-85d97661b72712021-10-08
50436-0123-3EA - Each50436-012388c585db-d38f-4495-9c99-f6b7f20eec8512021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0123METHOCARBAMOL TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 3 package rows20210822_10f701d6-d6ff-4462-8b0a-ac44e4a20489.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
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 TabletPSN10f701d6-d6ff-4462-8b0a-ac44e4a204892
197943methocarbamol 500 MG Oral TabletSCD10f701d6-d6ff-4462-8b0a-ac44e4a204892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50436-0123-35043601230390 TABLET, FILM COATED in 1 BOTTLE (50436-0123-3) 2021-08-200000-00-00NoNoCurrent