NDC 0143-9679-01 - 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: 0143-9679
Requested NDC: 0143-9679-01
Package NDCs from labels: 0143-9679-01, 0143-9679-10
Manufacturer: Henry Schein, Inc.
Effective date: 2025-08-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
GLYCOPYRROLATE - Henry Schein, Inc.	Henry Schein, Inc.	2025-08-18	HUMAN PRESCRIPTION DRUG LABEL
GLYCOPYRROLATE - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2025-01-08	HUMAN PRESCRIPTION DRUG LABEL
Glycopyrrolate - Medical Purchasing Solutions, LLC	Medical Purchasing Solutions, LLC	2023-06-01	HUMAN PRESCRIPTION DRUG LABEL
GLYCOPYRROLATE - General Injectables and Vaccines, Inc.	General Injectables and Vaccines, Inc.	2022-12-22	HUMAN PRESCRIPTION DRUG LABEL
WATER - Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	Hikma Pharmaceuticals USA Inc. \| HIKMA FARMACEUTICA (PORTUGAL), S.A	2022-03-23	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9679-01	Glycopyrrolate	20 mL in 1 VIAL	INJECTION	20		6
0143-9679-10	Glycopyrrolate	10 in 1 CARTON	INJECTION	10		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9679	GLYCOPYRROLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	6	Current NDC, Legacy NDC, 2 package rows	20220324_516cc4f8-3583-4405-ab66-29d4fcc56d05.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9679-01	ML - Milliliter	0143-9679	4b35b7dd-b08e-4a9f-a58e-d86aaaa852f3	1	2013-08-02
0143-9679-10	ML - Milliliter	0143-9679	4e1a21c2-b85c-41a6-a7a3-c0961c32bf05	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYCOPYRROLATE	ACTIVE INGREDIENT	V92SO9WP2I	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	2
GLYCOPYRRONIUM	ACTIVE MOIETY	A14FB57V1D	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]	2

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 15 of 16 · 308 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GLYCOPYRROLATE	GLYCOPYRROLATE	Novadoz Pharmaceuticals LLC	98820c01-1853-45d8-9da5-875fcdf5f9ab	2022-06-14	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Glycopyrrolate	GLYCOPYRROLATE	Xiromed LLC	29618edf-39b0-022a-9875-9d865450d318	2022-04-12	Warnings, Adverse reactions	Exact identifier rxcui: 1731582 rxcui: 1731590 rxcui: 238212 unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	Xiromed, LLC	f777c813-3232-d744-8bcf-58e86fb929bd	2022-04-12	Warnings, Adverse reactions	Exact identifier rxcui: 238212 unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	516cc4f8-3583-4405-ab66-29d4fcc56d05	2022-03-23	Warnings, Adverse reactions	Exact identifier application number: ANDA090963 ndc (package): 0143-9682-25 ndc (package): 0143-9682-01 ndc (package): 0143-9680-01 ndc (package): 0143-9679-10 ndc (package): 0143-9679-01 ndc (package): 0143-9681-01 ndc (package): 0143-9681-25 ndc (package): 0143-9680-25 ndc (product): 0143-9679 ndc (product): 0143-9682 ndc (product): 0143-9680 ndc (product): 0143-9681 ndc11 (package): 00143967901 rxcui: 1731582 rxcui: 1731590 rxcui: 238212 spl id: 8ed339c6-d65f-4b1c-8e23-301f75258c2e spl set id: 516cc4f8-3583-4405-ab66-29d4fcc56d05 unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	d5a18d74-0d40-46e2-aa0a-41d18609a536	2022-03-04	Warnings, Adverse reactions	Exact identifier application number: ANDA090963 rxcui: 1731582 rxcui: 1731590 rxcui: 238212 unii: V92SO9WP2I
glycopyrrolate	GLYCOPYRROLATE	BE Pharmaceuticals Inc.	d9df3900-a8c2-438b-8971-ba11ff91f90b	2022-02-24	Warnings, Adverse reactions	Exact identifier rxcui: 1731582 rxcui: 1731590 rxcui: 238212 unii: V92SO9WP2I
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Glycopyrrolate	GLYCOPYRROLATE	Somerset Therapeutics, LLC	a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6	2022-01-27	Warnings, Adverse reactions	Exact identifier rxcui: 1731582 rxcui: 1731590 rxcui: 238212 unii: V92SO9WP2I
Sterile Diluent for Treprostinil	WATER	Dr.Reddy's Laboratories Inc.,	33050ee2-519b-1f0b-d4df-9e14dd329c57	2021-12-23	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Glycopyrrolate	GLYCOPYRROLATE	AuroMedics Pharma LLC	eaebb511-1738-4d11-b9bb-317a8d41316a	2021-12-22	Warnings, Adverse reactions	Exact identifier rxcui: 1731582 rxcui: 1731590 rxcui: 238212 unii: V92SO9WP2I
GLYCOPYRROLATE	GLYCOPYRROLATE	Nivagen Pharmaceuticals, Inc.	7cb1ecbe-1e7a-4b39-8e1d-0c20f145e177	2021-10-29	Warnings, Adverse reactions	Exact identifier rxcui: 1731582 rxcui: 1731590 rxcui: 238212 unii: V92SO9WP2I
Sterile Water	STERILE WATER	B. Braun Medical Inc.	d99f9133-e4d0-4dee-b611-dbc3f918b547	2021-08-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8924e52e-8622-4ed6-a061-1908183e0a18	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Asclemed USA, Inc.	45c38269-883c-4198-a9d5-03810a4420ec	2021-01-14	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
GLYCOPYRROLATE	GLYCOPYRROLATE	Alembic Labs LLC	db178372-51d2-4194-bbe2-da9acb1cfd53	2020-12-09	Warnings, Adverse reactions	Exact identifier unii: V92SO9WP2I
Bach Original Flower Remedies	WATER	Nelson Bach USA Limited	09c76050-42c5-4403-865c-a1f6f668d9c0	2020-06-15	Warnings	Exact identifier unii: 059QF0KO0R
Glycopyrrolate	GLYCOPYRROLATE	Civica, Inc.	9f7f1ebf-58e8-4ae7-8157-1595df8ad6f4	2020-02-26	Warnings, Adverse reactions	Exact identifier application number: ANDA090963 rxcui: 1731582 unii: V92SO9WP2I
Sterile Water	WATER	Baxter Healthcare Company	8bcf5572-49e1-4302-9522-56f57904cb4a	2019-12-29	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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