Methocarbamol

Product NDC
70010-770
11-digit product format
700100770
Labeler code
70010
Product ID
70010-770_31b78323-4baf-4af7-e063-6394a90a2c79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Tablets
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA209312
Marketing category
ANDA
Marketing start
2018-07-02
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209312-001METHOCARBAMOL500MGTABLET / ORALAARS2018-05-07a50c72e98297…
2026-08-01 22:54:322026-06A209312-002METHOCARBAMOL750MGTABLET / ORALAARS2018-05-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209312-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A209312-002AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 70010-770
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL750 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197943Internal RxNorm lookup
197944Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6f0d3966-962d-fa7c-e053-2a91aa0a8e3cAvailable 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
70010-770-01Methocarbamol100 in 1 BOTTLETABLET, COATED1009
70010-770-05Methocarbamol500 in 1 BOTTLETABLET, COATED5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-770-01EA - Each70010-77093b9ddc4-bce3-41a7-bf09-178982f61aab12018-08-13
70010-770-05EA - Each70010-7703638125b-b74d-4809-8222-518ee6d970ca12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-770METHOCARBAMOL (METHOCARBAMOL TABLETS) TABLET, COATED [GRANULES PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 2 package rows20250403_6f0d3966-962d-fa7c-e053-2a91aa0a8e3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN37767123-8b72-4e1f-b00d-ff3305e9923f20
197944methocarbamol 750 MG Oral TabletSCD37767123-8b72-4e1f-b00d-ff3305e9923f20
197944methocarbamol 750 MG Oral TabletPSNd0acdf52-e1a9-4489-91e1-ef434d31161317
197944methocarbamol 750 MG Oral TabletSCDd0acdf52-e1a9-4489-91e1-ef434d31161317
197943methocarbamol 500 MG Oral TabletPSN31508051-c9cb-149b-e054-00144ff88e8816
197944methocarbamol 750 MG Oral TabletPSN31508051-c9cb-149b-e054-00144ff88e8816
197943methocarbamol 500 MG Oral TabletSCD31508051-c9cb-149b-e054-00144ff88e8816
197944methocarbamol 750 MG Oral TabletSCD31508051-c9cb-149b-e054-00144ff88e8816
197944methocarbamol 750 MG Oral TabletPSN2a99a422-6bad-4316-90bc-e7c2d1e3fb5311
197944methocarbamol 750 MG Oral TabletSCD2a99a422-6bad-4316-90bc-e7c2d1e3fb5311
197943methocarbamol 500 MG Oral TabletPSN6f0d3966-962d-fa7c-e053-2a91aa0a8e3c9
197944methocarbamol 750 MG Oral TabletPSN6f0d3966-962d-fa7c-e053-2a91aa0a8e3c9
197943methocarbamol 500 MG Oral TabletSCD6f0d3966-962d-fa7c-e053-2a91aa0a8e3c9
197944methocarbamol 750 MG Oral TabletSCD6f0d3966-962d-fa7c-e053-2a91aa0a8e3c9
197944methocarbamol 750 MG Oral TabletPSN71c21226-cd96-33ed-e053-2995a90a52698
197944methocarbamol 750 MG Oral TabletPSN7d4dd78a-f902-6ff2-e053-2991aa0ac7d78
197944methocarbamol 750 MG Oral TabletSCD7d4dd78a-f902-6ff2-e053-2991aa0ac7d78
197944methocarbamol 750 MG Oral TabletSCD71c21226-cd96-33ed-e053-2995a90a52698
197943methocarbamol 500 MG Oral TabletPSN21e2c2ef-3fee-4029-8837-23a476fcad5a7
197944methocarbamol 750 MG Oral TabletPSNaf73ae4b-bcf5-2e21-e053-2a95a90a2dce7
197944methocarbamol 750 MG Oral TabletPSN21e2c2ef-3fee-4029-8837-23a476fcad5a7
197943methocarbamol 500 MG Oral TabletSCD21e2c2ef-3fee-4029-8837-23a476fcad5a7
197944methocarbamol 750 MG Oral TabletSCDaf73ae4b-bcf5-2e21-e053-2a95a90a2dce7
197944methocarbamol 750 MG Oral TabletSCD21e2c2ef-3fee-4029-8837-23a476fcad5a7
197944methocarbamol 750 MG Oral TabletPSNf6193255-0e83-4510-bc86-30c926ee8fd16
197944methocarbamol 750 MG Oral TabletSCDf6193255-0e83-4510-bc86-30c926ee8fd16
197944methocarbamol 750 MG Oral TabletPSN43f83b87-e169-46fe-98bd-6af373595bd34
197944methocarbamol 750 MG Oral TabletSCD43f83b87-e169-46fe-98bd-6af373595bd34
197944methocarbamol 750 MG Oral TabletPSNf2b4ed5f-3489-9ee4-e053-2995a90a25f03
197944methocarbamol 750 MG Oral TabletSCDf2b4ed5f-3489-9ee4-e053-2995a90a25f03
197944methocarbamol 750 MG Oral TabletPSNf43a9389-c641-ce49-e053-2a95a90a537f2
197944methocarbamol 750 MG Oral TabletPSN6193ff74-cc55-4c99-882b-92a02961b5a52
197944methocarbamol 750 MG Oral TabletSCDf43a9389-c641-ce49-e053-2a95a90a537f2
197944methocarbamol 750 MG Oral TabletSCD6193ff74-cc55-4c99-882b-92a02961b5a52
197943methocarbamol 500 MG Oral TabletPSNedbcf8c6-0df8-4e72-885b-16d378f06c7b1
197944methocarbamol 750 MG Oral TabletPSNedbcf8c6-0df8-4e72-885b-16d378f06c7b1
197944methocarbamol 750 MG Oral TabletPSNe5fe4627-11cb-4ebd-8eb0-9be807446fdf1
197944methocarbamol 750 MG Oral TabletPSN911ec9f9-7d5b-5452-e053-2a95a90aea451
197944methocarbamol 750 MG Oral TabletPSN90b9b911-a1f3-cfe2-e053-2a95a90a927e1
197944methocarbamol 750 MG Oral TabletPSN90b98f8e-8805-520c-e053-2a95a90a31b81
197944methocarbamol 750 MG Oral TabletPSN3757cd8e-6054-4b75-bb04-d11f34c65cbe1
197944methocarbamol 750 MG Oral TabletPSN3e4c88fe-bc3d-463f-973c-e52062e4d4ba1
197944methocarbamol 750 MG Oral TabletPSN414b2fe0-fa2b-2b18-e063-6394a90ab2b91
197944methocarbamol 750 MG Oral TabletPSN46e983de-434e-7ff3-e063-6394a90aa4661
197943methocarbamol 500 MG Oral TabletSCDedbcf8c6-0df8-4e72-885b-16d378f06c7b1
197944methocarbamol 750 MG Oral TabletSCD911ec9f9-7d5b-5452-e053-2a95a90aea451
197944methocarbamol 750 MG Oral TabletSCD90b9b911-a1f3-cfe2-e053-2a95a90a927e1
197944methocarbamol 750 MG Oral TabletSCD90b98f8e-8805-520c-e053-2a95a90a31b81
197944methocarbamol 750 MG Oral TabletSCDe5fe4627-11cb-4ebd-8eb0-9be807446fdf1
197944methocarbamol 750 MG Oral TabletSCD3757cd8e-6054-4b75-bb04-d11f34c65cbe1
197944methocarbamol 750 MG Oral TabletSCDedbcf8c6-0df8-4e72-885b-16d378f06c7b1
197944methocarbamol 750 MG Oral TabletSCD3e4c88fe-bc3d-463f-973c-e52062e4d4ba1
197944methocarbamol 750 MG Oral TabletSCD414b2fe0-fa2b-2b18-e063-6394a90ab2b91
197944methocarbamol 750 MG Oral TabletSCD46e983de-434e-7ff3-e063-6394a90aa4661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70010-770-0170010077001100 TABLET, COATED in 1 BOTTLE (70010-770-01) 2020-02-010000-00-00NoNoCurrent
70010-770-0570010077005500 TABLET, COATED in 1 BOTTLE (70010-770-05) 2020-02-010000-00-00NoNoCurrent
70010-770-10700100770101000 TABLET, COATED in 1 BOTTLE (70010-770-10)2020-02-010Current
70010-770-357001007703524 TABLET, COATED in 1 BOTTLE (70010-770-35)2020-02-010Current