Methocarbamol

Product NDC
71610-833
Requested package NDC
71610-833-30
11-digit product format
716100833
Labeler code
71610
Product ID
71610-833_450e97b4-dff2-64a5-e063-6294a90a3455
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090200
Marketing category
ANDA
Marketing start
2024-02-02
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 43.

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
A090200-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2009-11-06
A090200-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2009-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090200-001AA
A090200-002AA

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0684e616aacf4f…
2026-09-14 22:38:342026-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0684e616aacf4f…
2026-08-18 06:07:402026-07A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090200-001METHOCARBAMOL500MGTABLET / ORALAA2009-11-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090200-002METHOCARBAMOL750MGTABLET / ORALAA2009-11-0674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090200-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A090200-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A090200-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A090200-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090200-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090200-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090200-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090200-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090200-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090200-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090200-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090200-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090200-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090200-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090200-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090200-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090200-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090200-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090200-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090200-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090200-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090200-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090200-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090200-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090200-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090200-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090200-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090200-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090200-002AA174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
18810520-3040-4802-e063-6294a90a1ec0Available 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
71610-833-30Methocarbamol30 in 1 BOTTLETABLET302
71610-833-53Methocarbamol60 in 1 BOTTLETABLET602
71610-833-60Methocarbamol90 in 1 BOTTLETABLET902
71610-833-70Methocarbamol120 in 1 BOTTLETABLET1202
71610-833-80Methocarbamol180 in 1 BOTTLETABLET1802
71610-833-90Methocarbamol240 in 1 BOTTLETABLET2402
71610-833-92Methocarbamol270 in 1 BOTTLETABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-833-30EA - Each71610-83373708a4e-c7f3-468f-844d-63408b5259d212026-03-17
71610-833-53EA - Each71610-8339443dd2f-ca26-42e7-97fd-1c025a2b974f12024-07-12
71610-833-60EA - Each71610-83328447a6d-bf0a-4254-bd15-8c1a417c23c612024-07-12
71610-833-70EA - Each71610-8339255f56e-2a05-434c-b086-450460cc5dd312024-07-12
71610-833-80EA - Each71610-83387e67146-3dcc-41e8-97e1-b97384fce03012024-07-12
71610-833-90EA - Each71610-8339df12ae0-3b59-41e0-a14a-7c6aaaba451212024-07-12
71610-833-92EA - Each71610-8333db18e07-9dd4-40ae-9a9a-47cadeb3551412024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-833METHOCARBAMOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 7 package rows20240517_18810520-3040-4802-e063-6294a90a1ec0.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 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLCardinal Health 107, LLC05b287d3-5004-4d8b-9ebe-a96caa2b8d892026-08-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLCoupler LLC5827d07b-a0a4-a543-e063-6294a90ad5652026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAmerican Health Packagingd842fe4e-fc46-4d70-9ca3-b47191672f962026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLUnit Dose Solutions, Inc.5539d4f6-1192-2770-e063-6394a90a1e502026-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
METHOCARBAMOLMETHOCARBAMOLDIRECT RX31508051-c9cb-149b-e054-00144ff88e882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAvPAKbe37bc85-6a41-00d8-e053-2a95a90ae5042026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNorthwind Health Company, LLCf31ccb09-7a9a-60af-e053-2995a90a6e972026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNorthwind Health Company, LLCdf63611f-90e4-6bbe-e053-2a95a90a2aad2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC18810520-3040-4802-e063-6294a90a1ec02025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
ndc (package): 71610-833-30
ndc (product): 71610-833
ndc11 (package): 71610083330
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9aed8304-fa4e-49d6-bd81-fcb3e4cc61732025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsff55df39-e314-4120-8fab-3757cbe5a8722025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLA-S Medication Solutions069045f1-d699-41d0-b674-cdb71cd5fbd02025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.eed9ebd1-c243-4e82-bf4e-5fec370e722e2025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLCoupler LLC2cee3893-70b7-6c2c-e063-6394a90aa79a2025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCf4e98f9f-b20b-8608-e053-2a95a90aa6b02024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f47c39b-9373-454f-9a4e-ba6dd65dd7a42024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackadd9e47f-11ac-e10d-bfc2-b9c52aa08fa52024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals,Inc.9d6024b2-ee1a-3a79-e053-2a95a90a1bf42024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLNuCare Pharmaceuticals, Inc.3e89a426-c741-2f44-e054-00144ff8d46c2024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200
MethocarbamolMETHOCARBAMOLAphena Pharma Solutions - Tennessee, LLC1880efb2-b97e-1e4d-e063-6294a90ab3e32024-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090200
application number: ANDA090200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197944methocarbamol 750 MG Oral TabletPSN18810520-3040-4802-e063-6294a90a1ec02
197944methocarbamol 750 MG Oral TabletSCD18810520-3040-4802-e063-6294a90a1ec02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-833-307161008333030 TABLET in 1 BOTTLE (71610-833-30) 30 tablet2025-12-01NoNoCurrent