methocarbamol

Product NDC
46672-873
11-digit product format
466720873
Labeler code
46672
Product ID
46672-873_a62ca835-bfee-bf62-e053-2a95a90a3c75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA212707
Marketing category
ANDA
Marketing start
2020-12-31
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
1000 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212707-001METHOCARBAMOLMETHOCARBAMOL1GMTABLET / ORALAB2023-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212707-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-128072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212707-001METHOCARBAMOL1GMTABLET / ORALAB2023-06-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212707-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212707-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212707-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212707-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212707-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212707-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212707-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212707-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212707-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212707-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212707-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212707-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212707-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212707-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212707-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212707-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212707-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212707-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212707-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212707-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212707-001AB1a67488948f0b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212707-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
methocarbamolMETHOCARBAMOLFH2 PHARMA LLC1dd56e3d-7ca7-1443-e063-6294a90a13c52025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212707
application number: ANDA212707
TanlorMETHOCARBAMOLForte Bio-Pharma1dd5f7fd-7b3b-8669-e063-6394a90abe952024-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212707
application number: ANDA212707

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46672-873-1046672087310100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46672-873-10) 2021-05-200000-00-00NoNoCurrent