FDA.reportPublic FDA data

NDC 70121-1396-01 - 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
70121-1396
Requested NDC
70121-1396-01
Package NDCs from labels
70121-1396-1, 70121-1396-5, 70121-1396-01
Manufacturer
Amneal Pharmaceuticals LLC
Effective date
2026-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate - Amneal Pharmaceuticals LLCAmneal Pharmaceuticals LLC2026-07-07HUMAN PRESCRIPTION DRUG LABEL
GLYCOPYRROLATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2025-01-08HUMAN PRESCRIPTION DRUG LABEL
GLYCOPYRROLATE - Henry Schein, Inc.Henry Schein, Inc.2024-10-14HUMAN PRESCRIPTION DRUG LABEL
GLYCOPYRROLATE - General Injectables and Vaccines, Inc.General Injectables and Vaccines, Inc.2022-12-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1396-1Glycopyrrolate5 mL in 1 VIALINJECTION510
70121-1396-5Glycopyrrolate25 in 1 CARTONINJECTION2510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1396GLYCOPYRROLATE INJECTION [AMNEAL PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 2 package rows20240730_bbab4cf1-0441-4fc4-9de9-e4117fa19faa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1396-1ML - Milliliter70121-1396d4667179-88ba-4933-ab97-5a9c291ac4a312017-07-07
70121-1396-5ML - Milliliter70121-1396b355673c-736f-490e-82ca-e7aedb8e8bf212017-07-07

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 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYCOPYRROLATEGLYCOPYRROLATEQUAGEN PHARMACEUTICALS LLC62e1ba35-bc84-4818-be54-8b534a1bf93c2026-09-10Warnings, Adverse reactionsExact identifier
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
rxcui: 1731590
unii: V92SO9WP2I
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
application number: ANDA208973
ndc (package): 70121-1394-5
ndc (package): 70121-1397-7
ndc (package): 70121-1396-1
ndc (package): 70121-1396-5
ndc (package): 70121-1395-1
ndc (package): 70121-1394-1
ndc (package): 70121-1395-5
ndc (package): 70121-1397-1
ndc (product): 70121-1396
ndc (product): 70121-1397
ndc (product): 70121-1394
ndc (product): 70121-1395
ndc11 (package): 70121139601
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
spl id: da35ede9-1b30-45a3-8600-f44a085a37f0
spl set id: bbab4cf1-0441-4fc4-9de9-e4117fa19faa
unii: V92SO9WP2I
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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