Methocarbamol

Product NDC
70069-101
11-digit product format
700690101
Labeler code
70069
Product ID
70069-101_dd175ad9-9f83-4ef1-b745-65e44f5e12c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA207522
Marketing category
ANDA
Marketing start
2017-07-31
Substance
METHOCARBAMOL
Active strength
100 mg/mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207522-001METHOCARBAMOLMETHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207522-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-313f01610625f2…
2019-09-15 20:21 UTC2019-09A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207522-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-07-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207522-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207522-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207522-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207522-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207522-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207522-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207522-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207522-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207522-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207522-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207522-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207522-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207522-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207522-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207522-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207522-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207522-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207522-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207522-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207522-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207522-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A207522-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207522-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207522-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207522-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A207522-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207522-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207522-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207522-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207522-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207522-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207522-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207522-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207522-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207522-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207522-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207522-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207522-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207522-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207522-001AP1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL100 mg/mL

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
238175Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
68dd9c24-4d41-48be-9f54-fceb787bb443Available 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
70069-101-05Methocarbamol10 mL in 1 VIALINJECTION108
70069-101-05Methocarbamol5 in 1 CARTONINJECTION58
70069-101-10Methocarbamol10 in 1 CARTONINJECTION108
70069-101-10Methocarbamol10 mL in 1 VIALINJECTION108
70069-101-25Methocarbamol25 in 1 CARTONINJECTION258
70069-101-25Methocarbamol10 mL in 1 VIALINJECTION108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-101-01ML - Milliliter70069-101004ee8f4-5911-48f7-b5e3-ccf08d30dd9c12017-10-13
70069-101-05ML - Milliliter70069-101e7e64c0e-a829-4a5b-af58-fd917397d6a612017-10-13
70069-101-25ML - Milliliter70069-1012d3c9b25-a65c-419c-a7c9-7b04fe06990012017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-101METHOCARBAMOL INJECTION [SOMERSET THERAPEUTICS, LLC]8Current NDC, Legacy NDC, 6 package rows20250325_68dd9c24-4d41-48be-9f54-fceb787bb443.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLSomerset Therapeutics, LLC68dd9c24-4d41-48be-9f54-fceb787bb4432025-03-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207522
application number: ANDA207522
ndc (product): 70069-101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSN68dd9c24-4d41-48be-9f54-fceb787bb4438
23817510 ML methocarbamol 100 MG/ML InjectionSCD68dd9c24-4d41-48be-9f54-fceb787bb4438
238175methocarbamol 1000 MG per 10 ML InjectionSY68dd9c24-4d41-48be-9f54-fceb787bb4438

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-101-05700690101055 VIAL in 1 CARTON (70069-101-05) / 10 mL in 1 VIAL5 vial2017-07-310000-00-00NoNoCurrent
70069-101-107006901011010 VIAL in 1 CARTON (70069-101-10) / 10 mL in 1 VIAL10 vial2017-07-310000-00-00NoNoCurrent
70069-101-257006901012525 VIAL in 1 CARTON (70069-101-25) / 10 mL in 1 VIAL25 vial2017-07-310000-00-00NoNoCurrent