Methocarbamol

Product NDC
10135-665
Requested package NDC
10135-665-05
11-digit product format
101350665
Labeler code
10135
Product ID
10135-665_d258986c-63ef-465b-e053-2995a90a8005
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA208507
Marketing category
ANDA
Marketing start
2018-10-01
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
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 packagepackage10135-66510135-665-05IInactivated 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 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-665-01Methocarbamol100 in 1 BOTTLETABLET, FILM COATED1004
10135-665-05Methocarbamol500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-665-01EA - Each10135-665ff40d365-5265-4368-9abb-65e8fefb972912018-11-06
10135-665-05EA - Each10135-665b55e8bcc-4e51-4068-8853-90125388307012020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-665METHOCARBAMOL TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]4Legacy NDC, 2 package rows20211205_01baa84f-453e-4954-bdf1-276ad7d484a1.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 TabletPSN01baa84f-453e-4954-bdf1-276ad7d484a14
197944methocarbamol 750 MG Oral TabletPSN01baa84f-453e-4954-bdf1-276ad7d484a14
197943methocarbamol 500 MG Oral TabletSCD01baa84f-453e-4954-bdf1-276ad7d484a14
197944methocarbamol 750 MG Oral TabletSCD01baa84f-453e-4954-bdf1-276ad7d484a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10135-665-0510135066505500 TABLET, FILM COATED in 1 BOTTLE (10135-665-05) 2018-10-010000-00-00NoNoCurrent