Methocarbamol

Product NDC
70518-1723
Requested package NDC
70518-1723-2
11-digit product format
705181723
Labeler code
70518
Product ID
70518-1723_4961eca0-ebdd-ebda-e063-6294a90aa3cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA209312
Marketing category
ANDA
Marketing start
2018-12-10
Substance
METHOCARBAMOL
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 12 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…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209312-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A209312-002AA1caaa826d4ba7…
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…

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
125OD7737XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197943Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52b20439-6bf4-435e-817a-c3b3fc70846aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
492965be-47bc-38cf-57c4-5c5e0343abe5Product name620211028
02a01e9c-3f4e-c0ee-6542-be865127aea3Product name820190205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1723-0Methocarbamol30 in 1 BLISTER PACKTABLET, COATED3020
70518-1723-1Methocarbamol60 in 1 BOTTLE, PLASTICTABLET, COATED6020
70518-1723-2Methocarbamol30 in 1 BOTTLE, PLASTICTABLET, COATED3020
70518-1723-3Methocarbamol30 in 1 BOTTLE, PLASTICTABLET, COATED3020
70518-1723-4Methocarbamol30 in 1 BLISTER PACKTABLET, COATED3020
70518-1723-5Methocarbamol20 in 1 BOTTLE, PLASTICTABLET, COATED2020
70518-1723-6Methocarbamol60 in 1 BOTTLE, PLASTICTABLET, COATED6020
70518-1723-7Methocarbamol90 in 1 BOTTLE, PLASTICTABLET, COATED9020
70518-1723-8Methocarbamol15 in 1 BOTTLE, PLASTICTABLET, COATED1520
70518-1723-9Methocarbamol40 in 1 BOTTLE, PLASTICTABLET, COATED4020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-1723-6EA - Each70518-1723519e9686-ffc4-426f-ab5f-7e897b94c03112025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1723METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 10 package rows20250327_52b20439-6bf4-435e-817a-c3b3fc70846a.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.1dc3a5b1-c83b-406b-a59d-ce8075e4ccf92026-08-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
MethocarbamolMETHOCARBAMOL TABLETSREMEDYREPACK INC.52b20439-6bf4-435e-817a-c3b3fc70846a2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209312
application number: ANDA209312
ndc (package): 70518-1723-2
ndc (product): 70518-1723
ndc11 (package): 70518172302
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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN52b20439-6bf4-435e-817a-c3b3fc70846a20
197943methocarbamol 500 MG Oral TabletSCD52b20439-6bf4-435e-817a-c3b3fc70846a20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-1723-27051817230230 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-1723-2) 2019-04-16NoNoCurrent