FDA.reportPublic FDA data

ROBAXIN

Product NDC
0641-6103
11-digit product format
006416103
Labeler code
0641
Product ID
0641-6103_086ede61-af0e-4f2d-a51d-75a4c1d9f2a0
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
1959-06-16
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
0641-6103-01ROBAXIN10 mL in 1 VIALINJECTION108
0641-6103-10ROBAXIN10 in 1 CARTONINJECTION108
0641-6103-25ROBAXIN25 in 1 CARTONINJECTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6103-01ML - Milliliter0641-6103fea093a9-e51d-4877-9285-77155bc4380f12013-02-13
0641-6103-10ML - Milliliter0641-610386079302-612f-4f5d-8af4-0b2d1fa573d812024-03-12
0641-6103-25ML - Milliliter0641-6103e99128e7-032f-45f6-bb13-8e212a583b2612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOCARBAMOLACTIVE INGREDIENT125OD7737XROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
METHOCARBAMOLACTIVE MOIETY125OD7737XROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RROBAXIN (METHOCARBAMOL) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6103ROBAXIN (METHOCARBAMOL) INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 3 package rows20240412_090a3d3d-92c3-4c30-a648-436461f81702.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238175methocarbamol 1000 MG in 10 ML InjectionPSN090a3d3d-92c3-4c30-a648-436461f817028
207014ROBAXIN 1000 MG in 10 ML InjectionPSN090a3d3d-92c3-4c30-a648-436461f817028
20701410 ML methocarbamol 100 MG/ML Injection [Robaxin]SBD090a3d3d-92c3-4c30-a648-436461f817028
23817510 ML methocarbamol 100 MG/ML InjectionSCD090a3d3d-92c3-4c30-a648-436461f817028
238175methocarbamol 1000 MG per 10 ML InjectionSY090a3d3d-92c3-4c30-a648-436461f817028
207014Robaxin 1000 MG per 10 ML InjectionSY090a3d3d-92c3-4c30-a648-436461f817028

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6103-010064161030110 mL in 1 VIAL10 mlHistorical
0641-6103-100064161031010 VIAL in 1 CARTON (0641-6103-10) / 10 mL in 1 VIAL (0641-6103-01) 10 vial2023-10-04NoNoCurrent
0641-6103-250064161032525 VIAL in 1 CARTON (0641-6103-25) / 10 mL in 1 VIAL (0641-6103-01) 25 vial1959-06-160000-00-00NoNoCurrent