Methocarbamol

Product NDC
49396-0711
11-digit product format
493960711
Labeler code
49396
Product ID
49396-0711_7d658860-a6e3-cb2f-e053-2991aa0a9461
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol Injection
Dosage form
INJECTION
Route
PARENTERAL
Labeler
Renaissance Lakewood LLC
Application
ANDA208116
Marketing category
ANDA
Marketing start
2017-03-10
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
100 mg/mL
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49396-0711DDiscontinued by firm2026-08-11
excluded packagepackage49396-071149396-0711-1DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49396-0711-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49396-0711-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49396-0711-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49396-0711-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49396-0711-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49396-0711-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49396-0711-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49396-0711-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49396-0711-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49396-0711-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49396-0711-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49396-0711-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49396-0711-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49396-0711-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49396-0711-1IInactivated by FDAbd6a592717d7…303034d00443…

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
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 · 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 UTC2026-02A208116-001METHOCARBAMOL1GM/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…
2022-09-29 23:25 UTC2022-09A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208116-001METHOCARBAMOL1GM/10ML (100MG/ML)SOLUTION / IM-IVAP2017-01-19cb3db0bc1861…

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 UTC2026-02A208116-001AP1011fe1cb6892…
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…
2022-09-29 23:25 UTC2022-09A208116-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208116-001AP1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49396-0711-12023-03-03C16284748780-1d6a99b39-3548-a426-e053-dadaa90af4c2Methocarbamol Injection USP
49396-0711-12022-01-28C16284748780-1d6a99b39-3548-a426-e053-dadaa90af4c2Methocarbamol Injection USP

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49396-0711-14939607110125 VIAL in 1 CARTON (49396-0711-1) > 10 mL in 1 VIAL25 vial2017-03-100000-00-00NoNoCurrent