Methocarbamol

Product NDC
63629-1623
11-digit product format
636291623
Labeler code
63629
Product ID
63629-1623_2f6a5693-afb3-483d-8eca-19142d7c58df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040489
Marketing category
ANDA
Marketing start
2003-01-29
Marketing end
0000-00-00
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1623DDiscontinued by firm2026-08-03
excluded packagepackage63629-162363629-1623-0DDiscontinued by firm2026-08-03
excluded packagepackage63629-162363629-1623-1DDiscontinued by firm2026-08-03
excluded packagepackage63629-162363629-1623-2DDiscontinued by firm2026-08-03
excluded packagepackage63629-162363629-1623-3DDiscontinued by firm2026-08-03
excluded packagepackage63629-162363629-1623-4DDiscontinued by firm2026-08-03
excluded packagepackage63629-162363629-1623-5DDiscontinued by firm2026-08-03
excluded packagepackage63629-162363629-1623-6DDiscontinued by firm2026-08-03
excluded packagepackage63629-162363629-1623-7DDiscontinued by firm2026-08-03
excluded packagepackage63629-162363629-1623-8DDiscontinued by firm2026-08-03
excluded packagepackage63629-162363629-1623-9DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040489-001METHOCARBAMOL500MGTABLET / ORALAA2003-01-29a50c72e98297…
2026-08-01 22:54:322026-06A040489-002METHOCARBAMOL750MGTABLET / ORALAA2003-01-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040489-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A040489-002AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 50 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.3d4a2486-863e-4e9f-be3b-67882863e7d42026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.6b9ed3a4-46d5-462e-ac93-6b959b314d772026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.adb49cb7-8900-44dc-add0-22e2cd8235ac2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPD-Rx Pharmaceuticals, Inc.0deb5368-ffdc-40fc-a97c-ba89b7a97e502026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutions9617e2b0-4255-4542-95ca-9ee1818ca4502026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLHAWAII REPACK, INC.8643032a-c491-4ae4-ac46-5e0c4c79dc5b2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutionscfdc0d68-00ad-44d6-b932-819cc3d5d60e2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLA-S Medication Solutionsb81a8e64-ae41-409b-94a6-b36cb50bc25d2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLHAWAII REPACK, INC.c4744824-4c74-411d-aa8e-c63ee9d899132026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals Inc.4ef1c2c0-31e1-4f85-b645-ff47a057a9942026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLPreferred Pharmaceuticals, Inc425abc3b-2111-4fac-bf27-b685d1e657af2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLDirect_rx4c5c8933-a4b5-f9c2-e063-6294a90a6f002026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack5af36a83-2b36-4fe2-8c6a-61b5516214212026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepackcc004f5c-d5fc-48c5-9f37-c59b9c37e1132026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack9076b4ad-17be-4933-a975-7bf80cc92b492026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack3f8aed5d-ba8d-4c32-872b-08ab15240cc12026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLSt. Mary's Medical Park Pharmacyfd8cac57-9664-1fa0-e053-6294a90af8722026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack6466438c-4609-4554-8919-35710a1b556d2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack33f89a57-f65d-4e99-a3a3-690ef805d8692026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489
MethocarbamolMETHOCARBAMOLBryant Ranch Prepack6af87b4e-6507-4190-b043-a6d3b440314a2026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040489
application number: ANDA040489

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-1623-02021-04-22C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-12021-04-22C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-22021-04-22C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-32021-04-22C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-42021-04-22C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-52021-04-22C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-62021-04-22C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-72021-04-22C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-82021-04-22C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-92021-04-22C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-02020-01-31C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-12020-01-31C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-22020-01-31C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-32020-01-31C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-42020-01-31C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-52020-01-31C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-62020-01-31C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-72020-01-31C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-82020-01-31C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg
63629-1623-92020-01-31C16284748780-19d75b9d0-4348-f424-e053-dadaa90a57ceMethocarbamol Tablets, USP 500 mg Methocarbamol Tablets, USP 750 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1623-1EA - Each63629-1623510aa89b-fb54-4918-a866-5d04c6964f3012012-07-24
63629-1623-2EA - Each63629-16237b24ced8-8622-49a2-9bc2-cad2f7f31cc712012-07-24
63629-1623-3EA - Each63629-1623953763b2-b3a5-4610-9f30-744d5388bab612012-07-24
63629-1623-4EA - Each63629-162384b02767-8158-479e-b99d-39c08792798312012-07-24
63629-1623-5EA - Each63629-1623f8e9f13f-b86d-490e-90dd-98721f0a185312012-07-24
63629-1623-6EA - Each63629-1623b5dc8f99-3879-44f3-96ae-9eedb0d735b912012-07-24
63629-1623-7EA - Each63629-1623982c98e6-7990-496e-aaee-7218a5e27fda12012-07-24
63629-1623-8EA - Each63629-1623d92472e7-0918-4803-b16e-2cdd5d6b116412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]2
METHOCARBAMOLACTIVE MOIETY125OD7737XMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHOCARBAMOL TABLET [BRYANT RANCH PREPACK]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHOCARBAMOL TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHOCARBAMOL TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]2
WATERINACTIVE INGREDIENT059QF0KO0RMETHOCARBAMOL TABLET [BRYANT RANCH PREPACK]2