Methocarbamol

Product NDC
15014-910
11-digit product format
150140910
Labeler code
15014
Product ID
15014-910_35c044a6-90c1-55f8-e063-6294a90aad48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
TABLET
Route
ORAL
Labeler
GENTEX PHARMA, LLC
Application
ANDA040489
Marketing category
ANDA
Marketing start
2025-05-22
Substance
METHOCARBAMOL
Active strength
500 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

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#

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

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethocarbamolMETHOCARBAMOLGENTEX PHARMA, LLC35c044a6-90c0-55f8-e063-6294a90aad482025-05-22Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol tablets should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of methocarbamol has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, methocarbamol tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS , Pregnancy ) . Use i n Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS Adverse reactions reported coincident with the administration of methocarbamol include: Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting Hemic and lymphatic system: Leukopenia Immune system: Hypersensitivity reactions Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

Additional Listing Data#

Finished product
Yes
Brand name base
Methocarbamol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui197943

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
15014-910-10Methocarbamol100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15014-910-10EA - Each15014-910e7fd8b9a-9961-48ff-99a9-23147c326dcc12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197943methocarbamol 500 MG Oral TabletPSN4c5c8933-a4b5-f9c2-e063-6294a90a6f002
197943methocarbamol 500 MG Oral TabletSCD4c5c8933-a4b5-f9c2-e063-6294a90a6f002
197943methocarbamol 500 MG Oral TabletPSN077fa923-bee0-4b34-a52d-6f870bcb48281
197943methocarbamol 500 MG Oral TabletPSN311c79a5-1447-4fef-8726-ae003ef64db51
197943methocarbamol 500 MG Oral TabletPSN35c044a6-90c0-55f8-e063-6294a90aad481
197943methocarbamol 500 MG Oral TabletPSN4abc29e9-a0cc-06cf-e063-6294a90ad8741
197943methocarbamol 500 MG Oral TabletPSN4b1d8ac6-d25d-1c37-e063-6394a90aba291
197943methocarbamol 500 MG Oral TabletPSNb72a3fff-9710-4c60-8ca6-ed428377fc241
197943methocarbamol 500 MG Oral TabletPSNf4956165-3605-4ff3-9fd1-70157edc08ca1
197943methocarbamol 500 MG Oral TabletSCD077fa923-bee0-4b34-a52d-6f870bcb48281
197943methocarbamol 500 MG Oral TabletSCD311c79a5-1447-4fef-8726-ae003ef64db51
197943methocarbamol 500 MG Oral TabletSCD35c044a6-90c0-55f8-e063-6294a90aad481
197943methocarbamol 500 MG Oral TabletSCD4abc29e9-a0cc-06cf-e063-6294a90ad8741
197943methocarbamol 500 MG Oral TabletSCD4b1d8ac6-d25d-1c37-e063-6394a90aba291
197943methocarbamol 500 MG Oral TabletSCDb72a3fff-9710-4c60-8ca6-ed428377fc241
197943methocarbamol 500 MG Oral TabletSCDf4956165-3605-4ff3-9fd1-70157edc08ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
15014-910-1015014091010100 TABLET in 1 BOTTLE (15014-910-10) 100 tablet2025-05-22NoNoCurrent