Methocarbamol

Product NDC
63739-991
Requested package NDC
63739-991-10
11-digit product format
637390991
Labeler code
63739
Product ID
63739-991_c7bc55bf-4d5f-682b-e053-2995a90af285
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA209312
Marketing category
ANDA
Marketing start
2021-07-22
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 packagepackage63739-99163739-991-10DDiscontinued by firm2026-08-03

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63739-99163739-991-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A209312-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAARS2018-05-07
A209312-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAARS2018-05-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A209312-001AA
A209312-002AA

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 UTC2026-02A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209312-002METHOCARBAMOL750MGTABLET / ORALAA2018-05-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07782e0a99824c…

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 UTC2026-02A209312-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209312-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209312-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209312-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209312-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209312-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209312-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209312-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209312-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209312-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209312-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209312-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209312-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209312-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209312-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209312-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209312-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209312-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209312-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209312-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209312-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209312-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209312-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209312-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209312-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209312-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209312-002AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209312-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209312-002AA1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-991-10EA - Each63739-9911210623d-faa3-410a-af56-09b90449f2cf12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-991METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [MCKESSON CORPORATION DBA SKY PACKAGING]12Legacy NDC20250110_c7bc1e92-28cb-31ae-e053-2a95a90aeb3f.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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.52b20439-6bf4-435e-817a-c3b3fc70846a2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.37767123-8b72-4e1f-b00d-ff3305e9923f2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSUnit Dose Solutions, Inc.561ae476-9e1f-038a-e063-6394a90aa5c72026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSGranules Pharmaceuticals Inc.6f0d3966-962d-fa7c-e053-2a91aa0a8e3c2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSBryant Ranch Prepack65c460f6-6470-41ff-abb4-d9d54ecc52f72026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSSt. Mary's Medical Park Pharmacy7d4dd78a-f902-6ff2-e053-2991aa0ac7d72026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSPreferred Pharmaceuticals Inc.43f83b87-e169-46fe-98bd-6af373595bd32026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSPreferred Pharmaceuticals Inc.e03878d3-d780-4e7f-b828-20ac2a1099332026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSCoupler LLC52b87514-e6e0-ab57-e063-6394a90a6b232026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNuCare Pharmaceuticals,Inc.71c21226-cd96-33ed-e053-2995a90a52692026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSSt. Mary's Medical Park Pharmacyfaa81ad3-2bd2-d637-e053-6294a90a2d362026-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSProficient Rx LP23163bc1-dec7-41f6-baed-eedebfd6be7e2026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.1dc3a5b1-c83b-406b-a59d-ce8075e4ccf92026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSAdvanced Rx of Tennessee, LLC4de118fe-bd8e-6cc4-e063-6394a90a13202026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSAdvanced Rx of Tennessee, LLC4cefe51c-d824-a862-e063-6394a90a77172026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSRedpharm Drug44f264fd-bf40-bed9-e063-6294a90ac44a2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNuCare Pharmaceuticals,Inc.72f36d28-15d2-30f6-e053-2a91aa0ad1ce2026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNorthwind Health Company, LLCf2b4ed95-0469-393a-e053-2a95a90a98ed2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
METHOCARBAMOLMETHOCARBAMOLDIRECT RX31508051-c9cb-149b-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSNorthwind Health Company, LLCf2b4ed5f-3489-9ee4-e053-2995a90a25f02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-991-106373909911010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-991-10) > 10 TABLET, COATED in 1 BLISTER PACK10 blister pack2021-07-220000-00-00NoNoCurrent