Methocarbamol

Product NDC
55700-990
11-digit product format
557000990
Labeler code
55700
Product ID
55700-990_4489ad03-3edd-4411-b1ad-9a42c20a3938
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA040489
Marketing category
ANDA
Marketing start
2022-12-15
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct55700-990DDiscontinued by firm2026-10-05
excluded packagepackage55700-99055700-990-30DDiscontinued by firm2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040489-001METHOCARBAMOLMETHOCARBAMOL500MGTABLET / ORALAA2003-01-29
A040489-002METHOCARBAMOLMETHOCARBAMOL750MGTABLET / ORALAA2003-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A040489-001AA
A040489-002AA

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2984e616aacf4f…
2026-09-14 22:38:342026-08A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2984e616aacf4f…
2026-08-18 06:07:402026-07A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-2974a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A040489-001AA184e616aacf4f…
2026-09-14 22:38:342026-08A040489-002AA184e616aacf4f…
2026-08-18 06:07:402026-07A040489-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040489-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040489-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040489-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040489-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040489-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040489-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040489-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040489-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040489-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040489-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040489-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040489-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040489-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040489-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040489-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040489-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040489-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040489-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040489-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040489-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040489-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040489-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040489-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040489-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040489-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040489-002AA174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-990-30EA - Each55700-9902294af70-fcb8-4085-a394-b3ec2a741f8512023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-990METHOCARBAMOL TABLET [QUALITY CARE PRODUCTS, LLC]3Legacy NDC20241222_9878b1cd-8313-4dce-a0af-725f1bd47c29.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 2 of 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLDoc Rxf4956165-3605-4ff3-9fd1-70157edc08ca2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLOxford Pharmaceuticals, LLC06dc72a6-ef3a-425a-9194-a9d228093cc42026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackb72a3fff-9710-4c60-8ca6-ed428377fc242026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackd3448618-c9b4-4cb9-a30e-1afc8197cfe12026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLASCLEMED USA INC.077fa923-bee0-4b34-a52d-6f870bcb48282026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLProficient Rx LP311c79a5-1447-4fef-8726-ae003ef64db52026-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLAdvanced Rx of Tennessee, LLC4b1d8ac6-d25d-1c37-e063-6394a90aba292026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPHOENIX RX LLC4abc29e9-a0cc-06cf-e063-6294a90ad8742026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLProficient Rx LPe4ebe9cf-a274-47c7-b740-4b3d6e9dc52b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPHOENIX RX LLC39bc9ecf-837e-5bb8-e063-6394a90a917e2025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLDoc Rx5e55526f-bb34-4b67-85ea-b2765e8066bb2025-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLGENTEX PHARMA, LLC35c044a6-90c0-55f8-e063-6294a90aad482025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLAdvanced Rx of Tennessee, LLC2cf76cdc-820d-1c5b-e063-6294a90a35aa2025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLRedpharm Drug, Inc.09d22ef9-a472-4db9-e063-6394a90a88702025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
METHOCARBAMOLMETHOCARBAMOLDirectRxceb428e0-d6e4-57b7-e053-2995a90afcda2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLAdvanced Rx of Tennessee, LLCafc9d84d-c8dd-05c0-e053-2a95a90a22a22024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLAdvanced Rx Pharmacy of Tennessee, LLCf6567e04-12f0-fa79-e053-2995a90a9a0e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack8c18ffef-b2c5-4af2-af66-e22c168e76802024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLKey Therapeuticsa88a6c84-b55a-4b6b-ac01-554079f6e3042024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLKey Therapeuticscf931001-95bd-4900-98d5-f5ef54b49d992024-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-990-305570009903030 TABLET in 1 BOTTLE (55700-990-30) 30 tablet2022-12-150000-00-00NoNoCurrent