FDA.reportPublic FDA data

NDC 51672-5316-09 - Glycopyrrolate Oral Solution

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
51672-5316
Requested NDC
51672-5316-09
Package NDCs from labels
51672-5316-9, 51672-5316-09
Manufacturer
Sun Pharmaceutical Industries, Inc. | Suven Pharmaceuticals Limited
Effective date
2026-04-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate Oral Solution 1 mg/5 mLSun Pharmaceutical Industries, Inc. | Suven Pharmaceuticals Limited2026-04-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-5316-9Glycopyrrolate Oral Solution1 in 1 CARTONLIQUID15
51672-5316-9Glycopyrrolate Oral Solution500 mL in 1 BOTTLELIQUID5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5316GLYCOPYRROLATE ORAL SOLUTION LIQUID [TARO PHARMACEUTICALS U.S.A. INC.]3Current NDC, Legacy NDC, 2 package rows20240110_e20c9a89-2a81-3c6e-e053-2995a90a9861.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5316-9ML - Milliliter51672-5316b8e8ff5e-aeab-44cd-b36f-1c7c36790c7912022-08-04

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 1 of 6 · 120 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYCOPYRROLATEGLYCOPYRROLATEQUAGEN PHARMACEUTICALS LLC62e1ba35-bc84-4818-be54-8b534a1bf93c2026-09-10Warnings, Adverse reactionsExact identifier
rxcui: 999961
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackf7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c2026-09-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.4ecb3435-58e5-46cb-b8c2-85b5fd955f832026-09-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEPar Health USA, LLC1f266d77-4f9e-44c9-a000-2f8fea3ac80b2026-07-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEAmneal Pharmaceuticals LLCbbab4cf1-0441-4fc4-9de9-e4117fa19faa2026-07-07Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEPiramal Critical Care Inc83d70378-011b-4ce3-e053-2991aa0a22be2026-06-23Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATECardinal Health 107, LLC65688bed-0d70-4b51-8301-1948b1deade12026-06-02Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEREMEDYREPACK INC.220cd5f5-3d71-4fdb-9943-7468799c179f2026-06-02Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEGolden State Medical Supply, Inc.ec15e70c-8473-469a-9f07-ea668783fa072026-05-27Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMeitheal Pharmaceuticals Inc.02541cfd-b209-49b9-a73f-13ef18dce06d2026-05-20Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
TrimbowBECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATEChiesi USA, Inc.4e13e70f-f550-4603-bbfb-346f80df3c4f2026-05-20Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEPar Health USA, LLCff65c5d3-7ba9-4315-a884-199151eb45a52026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 999961
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack098c7654-a352-47ee-bf23-6a81f86012662026-05-05Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEAtlantic Biologicals Corp.50b493d7-8e3b-e459-e063-6394a90addbc2026-04-30Warnings, Adverse reactionsExact identifier
rxcui: 999961
unii: V92SO9WP2I
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
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack21c7d201-c0b8-4f16-be4a-681d0b22791e2026-04-03Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Glycopyrrolate Oral SolutionGLYCOPYRROLATE ORAL SOLUTIONSun Pharmaceutical Industries, Inc.e20c9a89-2a81-3c6e-e053-2995a90a98612026-04-02Warnings, Adverse reactionsExact identifier
application number: ANDA212467
ndc (package): 51672-5316-9
ndc (product): 51672-5316
ndc11 (package): 51672531609
rxcui: 999961
spl id: 4e7def49-5c38-4c64-e063-6394a90a33c2
spl set id: e20c9a89-2a81-3c6e-e053-2995a90a9861
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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