NDC 70518-4597-01 - 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: 70518-4597
Requested NDC: 70518-4597-01
Package NDCs from labels: 70518-4597-1, 70518-4597-0, 70518-4597-01
Manufacturer: REMEDYREPACK INC.
Effective date: 2026-03-26
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Glycopyrrolate - REMEDYREPACK INC.	REMEDYREPACK INC.	2026-03-26	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4597-0	Glycopyrrolate	100 in 1 BOX	TABLET	100		1
70518-4597-1	Glycopyrrolate	1 in 1 POUCH	TABLET	1		1

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 10 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	26cdd84d-ffa0-4e52-b359-4acef4bd8093	2022-11-10	Warnings, Adverse reactions	Exact identifier application number: ANDA207201 ndc (product): 23155-606 rxcui: 197739 rxcui: 197738 spl id: d512ee19-1141-4887-b0ab-123d408b5515 spl set id: 26cdd84d-ffa0-4e52-b359-4acef4bd8093 unii: V92SO9WP2I
Saccharum Lactis	SACCHARUM LACTIS	Hahnemann Laboratories, INC.	e6f02163-2845-680d-e053-2a95a90ae43a	2022-08-23		Exact identifier unii: J2B2A4N98G
Glycopyrrolate	GLYCOPYRROLATE	Camber Pharmaceuticals, Inc.	4741be85-3abb-4545-aba9-281f64d210ec	2022-07-13	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
GLYCOPYRROLATE	GLYCOPYRROLATE	Novadoz Pharmaceuticals LLC	98820c01-1853-45d8-9da5-875fcdf5f9ab	2022-06-14	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	Xiromed LLC	29618edf-39b0-022a-9875-9d865450d318	2022-04-12	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	Xiromed, LLC	f777c813-3232-d744-8bcf-58e86fb929bd	2022-04-12	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	516cc4f8-3583-4405-ab66-29d4fcc56d05	2022-03-23	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	d5a18d74-0d40-46e2-aa0a-41d18609a536	2022-03-04	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
glycopyrrolate	GLYCOPYRROLATE	BE Pharmaceuticals Inc.	d9df3900-a8c2-438b-8971-ba11ff91f90b	2022-02-24	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	Somerset Therapeutics, LLC	a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6	2022-01-27	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	AuroMedics Pharma LLC	eaebb511-1738-4d11-b9bb-317a8d41316a	2021-12-22	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
GLYCOPYRROLATE	GLYCOPYRROLATE	Nivagen Pharmaceuticals, Inc.	7cb1ecbe-1e7a-4b39-8e1d-0c20f145e177	2021-10-29	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
GLYCOPYRROLATE	GLYCOPYRROLATE	Alembic Labs LLC	db178372-51d2-4194-bbe2-da9acb1cfd53	2020-12-09	Warnings, Adverse reactions	Exact identifier rxcui: 197739 rxcui: 197738 unii: V92SO9WP2I
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9a61f1ae-d3a4-68d7-e053-2a95a90a4333	2020-12-03	Warnings	Exact identifier unii: J2B2A4N98G
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9aefc830-329c-5e35-e053-2a95a90a6ffe	2020-11-30	Warnings	Exact identifier unii: J2B2A4N98G
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9af2d6f4-baa8-5da9-e053-2995a90a3dac	2020-11-30	Warnings	Exact identifier unii: J2B2A4N98G
Glycopyrrolate	GLYCOPYRROLATE	Civica, Inc.	9f7f1ebf-58e8-4ae7-8157-1595df8ad6f4	2020-02-26	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	Dr. Reddy's Laboratories Limited	725529e8-9c4b-4108-690a-e4f391439736	2016-11-15	Warnings, Adverse reactions	Exact identifier rxcui: 197738 unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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