NDC 65145-103-01 - 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: 65145-103
Requested NDC: 65145-103-01
Package NDCs from labels: 65145-103-01, 65145-103-25
Manufacturer: Caplin Steriles Limited
Effective date: 2025-01-25
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Glycopyrrolate - Caplin Steriles Limited	Caplin Steriles Limited	2025-01-25	Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65145-103-01	Glycopyrrolate	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2		5
65145-103-25	Glycopyrrolate	25 in 1 CARTON	INJECTION	25		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65145-103	GLYCOPYRROLATE INJECTION [CAPLIN STERILES LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20250126_765490fa-8378-40c8-9fa7-b0bfa2e1a0a9.zip

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 16 of 17 · 330 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 rxcui: 1731582 rxcui: 1731590 rxcui: 238212 unii: V92SO9WP2I
Glycopyrrolate	GLYCOPYRROLATE	Hikma Pharmaceuticals USA Inc.	d5a18d74-0d40-46e2-aa0a-41d18609a536	2022-03-04	Warnings, Adverse reactions	Exact identifier 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 application number: ANDA211705 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 application number: ANDA211705 rxcui: 1731582 rxcui: 1731590 rxcui: 238212 unii: V92SO9WP2I
BHI Hemorrhoid	HORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFUR	MediNatura Inc	d7df7d3e-48ad-4f58-aef5-a7bd48d2f191	2022-01-05	Warnings	Exact identifier unii: QTT17582CB
Joette Calabrese Survivalist Kit	ABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIP	OHM PHARMA INC.	1ac2a2c4-704e-4efa-aa44-acc71d300f70	2021-12-29	Warnings	Exact identifier unii: QTT17582CB
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
Fungisode	ARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHUR	Seroyal USA	55c5dfc4-3757-6ac2-e054-00144ff88e88	2021-07-22	Warnings	Exact identifier unii: QTT17582CB
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

Reported adverse events (FAERS/openFDA)#

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