Methocarbamol

Product NDC
43598-839
11-digit product format
435980839
Labeler code
43598
Product ID
43598-839_87da81ae-2159-f914-da9a-e6de28a93433
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Dr.Reddy�s Laboratories Inc.,
Application
ANDA211504
Marketing category
ANDA
Marketing start
2019-03-07
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
A211504-001METHOCARBAMOLMETHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211504-001AP

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 UTC2026-02A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-263f01610625f2…
2019-09-15 20:21 UTC2019-09A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211504-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2018-10-26cb3db0bc1861…

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 UTC2026-02A211504-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211504-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211504-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211504-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211504-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211504-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211504-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211504-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211504-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211504-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211504-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211504-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211504-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211504-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211504-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211504-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211504-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211504-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211504-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211504-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211504-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A211504-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211504-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211504-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211504-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A211504-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211504-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211504-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211504-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211504-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211504-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211504-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211504-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211504-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211504-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211504-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211504-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211504-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211504-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211504-001AP1cb3db0bc1861…

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
c88898af-5cd8-7bed-a03e-2ab4488e2040Available 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
43598-839-11Methocarbamol10 mL in 1 VIALINJECTION102
43598-839-36Methocarbamol10 in 1 CARTONINJECTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-839-11ML - Milliliter43598-83937168d03-5bb8-45db-9a7f-04457330dda512019-04-11
43598-839-36ML - Milliliter43598-839298952b3-0aba-4eda-b891-87ab66bc5c0d12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-839METHOCARBAMOL INJECTION [DR.REDDY’S LABORATORIES INC.,]2Current NDC, Legacy NDC, 2 package rows20190312_c88898af-5cd8-7bed-a03e-2ab4488e2040.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLJVET PHARMACEUTICALS LLCd9e4748f-11c5-4d87-b260-1be94febe8062026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211504
application number: ANDA211504
MethocarbamolMETHOCARBAMOLSagent Pharmaceuticals01e7e2c7-49eb-4afb-a496-f2bd901622e92025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211504
application number: ANDA211504
MethocarbamolMETHOCARBAMOLGland Pharma Limited44c7fe99-8999-4747-9376-f13d3f9e56882020-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211504
application number: ANDA211504
MethocarbamolMETHOCARBAMOLMeitheal Pharmaceuticals Inc.b60000fc-e99b-4994-9d36-3907e0da9e062019-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211504
application number: ANDA211504
MethocarbamolMETHOCARBAMOLDr.Reddys Laboratories Inc.,c88898af-5cd8-7bed-a03e-2ab4488e20402018-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211504
application number: ANDA211504
ndc (product): 43598-839

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSNc88898af-5cd8-7bed-a03e-2ab4488e20402
23817510 ML methocarbamol 100 MG/ML InjectionSCDc88898af-5cd8-7bed-a03e-2ab4488e20402
238175methocarbamol 1000 MG per 10 ML InjectionSYc88898af-5cd8-7bed-a03e-2ab4488e20402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-839-114359808391110 mL in 1 VIAL10 mlHistorical
43598-839-364359808393610 VIAL in 1 CARTON (43598-839-36) / 10 mL in 1 VIAL (43598-839-11) 10 vial2019-03-070000-00-00NoNoCurrent