FDA.reportPublic FDA data

ROBAXIN

Product NDC
0641-6217
11-digit product format
006416217
Labeler code
0641
Product ID
0641-6217_2d52b3d7-dd93-47a3-95cf-7d4d50de5b18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methocarbamol
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA011790
Marketing category
NDA
Marketing start
2017-10-17
Substance
METHOCARBAMOL
Active strength
100 mg/mL
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOCARBAMOL100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii125OD7737X
Rxcui207014, 238175

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
0641-6217-01ROBAXIN10 mL in 1 VIALINJECTION107
0641-6217-10ROBAXIN10 in 1 CARTONINJECTION107
0641-6217-25ROBAXIN25 in 1 CARTONINJECTION257

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6217-01ML - Milliliter0641-62172438936d-92e9-4049-b7e6-e5cd29d24ec412018-04-19
0641-6217-10ML - Milliliter0641-62176b59dbca-486a-44fe-873d-0de61865480a12024-05-16
0641-6217-25ML - Milliliter0641-621762677966-065d-4f14-b2de-140ea2a4e67e12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6217ROBAXIN (METHOCARBAMOL) INJECTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 3 package rows20240412_a418c43a-afe8-4a19-a57a-95c8dbe3d3d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSNa418c43a-afe8-4a19-a57a-95c8dbe3d3d87
207014ROBAXIN 1000 MG in 10 ML InjectionPSNa418c43a-afe8-4a19-a57a-95c8dbe3d3d87
20701410 ML methocarbamol 100 MG/ML Injection [Robaxin]SBDa418c43a-afe8-4a19-a57a-95c8dbe3d3d87
23817510 ML methocarbamol 100 MG/ML InjectionSCDa418c43a-afe8-4a19-a57a-95c8dbe3d3d87
238175methocarbamol 1000 MG per 10 ML InjectionSYa418c43a-afe8-4a19-a57a-95c8dbe3d3d87
207014Robaxin 1000 MG per 10 ML InjectionSYa418c43a-afe8-4a19-a57a-95c8dbe3d3d87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6217-010064162170110 mL in 1 VIAL10 mlHistorical
0641-6217-100064162171010 VIAL in 1 CARTON (0641-6217-10) / 10 mL in 1 VIAL (0641-6217-01) 10 vial2023-10-04NoNoCurrent
0641-6217-250064162172525 VIAL in 1 CARTON (0641-6217-25) / 10 mL in 1 VIAL (0641-6217-01) 25 vial2017-10-170000-00-00NoNoCurrent