methocarbamol

Product NDC
70436-149
11-digit product format
704360149
Labeler code
70436
Product ID
70436-149_1b9bb15b-be83-927b-e063-6394a90aed3a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA208116
Marketing category
ANDA
Marketing start
2024-07-01
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 43.

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
A208116-001METHOCARBAMOLMETHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208116-001AP

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-1984e616aacf4f…
2026-08-18 06:07:402026-07A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-193f01610625f2…
2019-09-15 20:21 UTC2019-09A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208116-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A208116-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208116-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208116-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208116-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208116-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208116-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208116-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208116-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208116-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208116-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208116-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208116-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208116-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208116-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208116-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208116-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208116-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208116-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208116-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208116-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208116-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208116-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A208116-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208116-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208116-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208116-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A208116-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208116-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208116-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208116-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208116-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208116-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208116-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208116-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208116-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208116-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208116-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208116-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208116-001AP1f41ea6bd6efb…

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
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
bc16295e-f3aa-4ed5-9fd6-ac4c750e0bbaAvailable 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
70436-149-33methocarbamol10 mL in 1 VIAL, SINGLE-DOSEINJECTION101
70436-149-55methocarbamol25 in 1 CARTONINJECTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-149METHOCARBAMOL INJECTION [SLATE RUN PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20240701_bc16295e-f3aa-4ed5-9fd6-ac4c750e0bba.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
methocarbamolMETHOCARBAMOLSlate Run Pharmaceuticals, LLCbc16295e-f3aa-4ed5-9fd6-ac4c750e0bba2024-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208116
application number: ANDA208116
ndc (product): 70436-149

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSNbc16295e-f3aa-4ed5-9fd6-ac4c750e0bba1
23817510 ML methocarbamol 100 MG/ML InjectionSCDbc16295e-f3aa-4ed5-9fd6-ac4c750e0bba1
238175methocarbamol 1000 MG per 10 ML InjectionSYbc16295e-f3aa-4ed5-9fd6-ac4c750e0bba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70436-149-337043601493310 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
70436-149-557043601495525 VIAL, SINGLE-DOSE in 1 CARTON (70436-149-55) / 10 mL in 1 VIAL, SINGLE-DOSE (70436-149-33) 2024-07-01NoNoCurrent