Robinul

Product NDC
0641-6105
11-digit product format
006416105
Labeler code
0641
Product ID
0641-6105_e4a973a8-5fc7-43d8-9bbe-14ce4cb7ded2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Robinul
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
West-Ward Pharmaceuticals Corp.
Application
NDA017558
Marketing category
NDA
Marketing start
1975-02-06
Marketing end
0000-00-00
Substance
GLYCOPYRROLATE
Active strength
0 mg/mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6105-01ML - Milliliter0641-610550c57b9c-293b-4334-b3d4-2bdee7d283f312013-02-13
0641-6105-25ML - Milliliter0641-6105d137eb9a-ba34-4fb4-80da-c5bdac7c916b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
GLYCOPYRROLATEACTIVE MOIETYV92SO9WP2IROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6105ROBINUL INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3Legacy NDC20171202_38f88829-a226-4810-866c-1b62c47e8aee.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6105-250064161052525 VIAL in 1 CARTON (0641-6105-25) > 2 mL in 1 VIAL (0641-6105-01) 25 vial1975-02-060000-00-00NoNoCurrent