FDA.reportPublic FDA data

NDC 63304-211-11 - Glycopyrrolate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63304-211
Requested NDC
63304-211-11
Package NDCs from labels
63304-211-30, 63304-211-01, 63304-211-10, 63304-211-11, 63304-211-69
Manufacturer
Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date
2013-01-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GLYCOPYRROLATE TABLETS, USP Rx onlyRanbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.2013-01-03HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
63304-211-01GLYCOPYRROLATE TABLETS, USP Rx only
63304-211-10GLYCOPYRROLATE TABLETS, USP Rx only
63304-211-30GLYCOPYRROLATE TABLETS, USP Rx only
63304-211-69GLYCOPYRROLATE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-211-01Glycopyrrolate100 in 1 BOTTLETABLET1003
63304-211-10Glycopyrrolate1000 in 1 BOTTLETABLET10003
63304-211-11Glycopyrrolate10 in 1 BLISTER PACKTABLET103
63304-211-30Glycopyrrolate30 in 1 BOTTLETABLET303
63304-211-69Glycopyrrolate1 in 1 BOXTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-211GLYCOPYRROLATE TABLET [RANBAXY PHARMACEUTICALS INC.]3Legacy NDC, 5 package rows20130214_4ec4e4e4-ce23-463b-9296-bff35b005632.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE TABLET [RANBAXY PHARMACEUTICALS INC.]3
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DGLYCOPYRROLATE TABLET [RANBAXY PHARMACEUTICALS INC.]3
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JGLYCOPYRROLATE TABLET [RANBAXY PHARMACEUTICALS INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLYCOPYRROLATE TABLET [RANBAXY PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYCOPYRROLATE TABLET [RANBAXY PHARMACEUTICALS INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLYCOPYRROLATE TABLET [RANBAXY PHARMACEUTICALS INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYCOPYRROLATE TABLET [RANBAXY PHARMACEUTICALS INC.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack098c7654-a352-47ee-bf23-6a81f86012662026-05-05Warnings, Adverse reactionsExact identifier
rxcui: 197739
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEAtlantic Biologicals Corp.50b493d7-8e3b-e459-e063-6394a90addbc2026-04-30Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
GlycopyrrolateGLYCOPYRROLATEGland Pharma Limitedd670bd26-8a44-44be-90e1-107d4c3802332026-04-28Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
glycopyrrolateGLYCOPYRROLATEAmneal Pharmaceuticals LLC741355f5-b695-41bb-a065-4abc687312b22026-04-28Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
BREZTRIBUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATEAstraZeneca Pharmaceuticals LP715433dc-cb2b-43ea-b6df-c5b4177adc6c2026-04-27Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATESagent Pharmaceuticals55930f87-8964-43b1-b790-c1e6dd2602d22026-04-20Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack21c7d201-c0b8-4f16-be4a-681d0b22791e2026-04-03Warnings, Adverse reactionsExact identifier
rxcui: 197738
unii: V92SO9WP2I
Glycopyrrolate Oral SolutionGLYCOPYRROLATE ORAL SOLUTIONSun Pharmaceutical Industries, Inc.e20c9a89-2a81-3c6e-e053-2995a90a98612026-04-02Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATESandoz Inccb1ae370-ec4f-4114-9860-8f736f72b5452026-04-01Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEREMEDYREPACK INC.a338ef22-c243-4075-b02d-bcd5b590104a2026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 197738
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEREMEDYREPACK INC.fafea739-87d0-4421-833f-eb066791504c2026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 197739
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATELifestar Pharma LLC0f4a4b94-71e0-49ed-8f1e-c760e4dd31372026-03-25Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMajor Pharmaceuticals6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a2026-03-19Warnings, Adverse reactionsExact identifier
rxcui: 197738
unii: V92SO9WP2I
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
glycopyrrolateGLYCOPYRROLATEBionpharma Inc.512d3f1e-c35c-87c2-e063-6394a90a8de02026-03-05Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATENCS HealthCare of KY, LLC dba Vangard Labs5ed930b7-a36e-4bf8-b1d1-dad238d3dd182026-02-25Warnings, Adverse reactionsExact identifier
rxcui: 197738
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack10ea264f-e157-4e13-9d79-b4228daf359d2026-02-17Warnings, Adverse reactionsExact identifier
rxcui: 197738
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.