NDC 0517-4601-01 - 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
- 0517-4601
- Requested NDC
- 0517-4601-01
- Package NDCs from labels
- 0517-4601-01, 0517-4601-25
- Manufacturer
- American Regent, Inc.
- Effective date
- 2024-02-07
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| GLYCOPYRROLATE INJECTION, USP | American Regent, Inc. | 2024-02-07 | HUMAN PRESCRIPTION DRUG LABEL |
| Glycopyrrolate - Cardinal Health | Cardinal Health | 2019-09-26 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0517-4601-25 | Glycopyrrolate | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | 11 | |
| 0517-4601-25 | Glycopyrrolate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 11 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0517-4601-25 | ML - Milliliter | 0517-4601 | a9213cd6-593f-4b41-bd86-98c15c66fde8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| GLYCOPYRROLATE | ACTIVE INGREDIENT | V92SO9WP2I | GLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 5 | |
| GLYCOPYRRONIUM | ACTIVE MOIETY | A14FB57V1D | GLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 5 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | GLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GLYCOPYRROLATE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 5 | |
| GLYCOPYRROLATE | ACTIVE INGREDIENT | V92SO9WP2I | GLYCOPYRROLATE INJECTION, SOLUTION [CARDINAL HEALTH] | 3 | |
| GLYCOPYRRONIUM | ACTIVE MOIETY | A14FB57V1D | GLYCOPYRROLATE INJECTION, SOLUTION [CARDINAL HEALTH] | 3 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | GLYCOPYRROLATE INJECTION, SOLUTION [CARDINAL HEALTH] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | GLYCOPYRROLATE INJECTION, SOLUTION [CARDINAL HEALTH] | 3 |
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.
| 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 | V92SO9WP2I |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | b45e9f1d-9c48-4b46-8541-d846b89540df | 2022-10-26 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye wash | PURIFIED WATER | McKesson | bd089fde-24ba-4de5-e053-2995a90a39bb | 2022-10-18 | Warnings | 059QF0KO0R |
| Bach Original Flower Remedies Rock Water | WATER | Nelson Bach USA Limited | ea242559-1618-3354-e053-2a95a90a1a95 | 2022-10-03 | Warnings | 059QF0KO0R |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| Glycopyrrolate | GLYCOPYRROLATE | Camber Pharmaceuticals, Inc. | 4741be85-3abb-4545-aba9-281f64d210ec | 2022-07-13 | Warnings, Adverse reactions | V92SO9WP2I |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Novadoz Pharmaceuticals LLC | 98820c01-1853-45d8-9da5-875fcdf5f9ab | 2022-06-14 | Warnings, Adverse reactions | V92SO9WP2I |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Glycopyrrolate | GLYCOPYRROLATE | Xiromed LLC | 29618edf-39b0-022a-9875-9d865450d318 | 2022-04-12 | Warnings, Adverse reactions | 1731582 1731590 238212 V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Xiromed, LLC | f777c813-3232-d744-8bcf-58e86fb929bd | 2022-04-12 | Warnings, Adverse reactions | 238212 V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Hikma Pharmaceuticals USA Inc. | 516cc4f8-3583-4405-ab66-29d4fcc56d05 | 2022-03-23 | Warnings, Adverse reactions | 1731582 1731590 238212 V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Hikma Pharmaceuticals USA Inc. | d5a18d74-0d40-46e2-aa0a-41d18609a536 | 2022-03-04 | Warnings, Adverse reactions | 1731582 1731590 238212 V92SO9WP2I |
| glycopyrrolate | GLYCOPYRROLATE | BE Pharmaceuticals Inc. | d9df3900-a8c2-438b-8971-ba11ff91f90b | 2022-02-24 | Warnings, Adverse reactions | 1731582 1731590 238212 V92SO9WP2I |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Glycopyrrolate | GLYCOPYRROLATE | Somerset Therapeutics, LLC | a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6 | 2022-01-27 | Warnings, Adverse reactions | 1731582 1731590 238212 V92SO9WP2I |
| Treprostinil | TREPROSTINIL | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| Glycopyrrolate | GLYCOPYRROLATE | AuroMedics Pharma LLC | eaebb511-1738-4d11-b9bb-317a8d41316a | 2021-12-22 | Warnings, Adverse reactions | 1731582 1731590 238212 V92SO9WP2I |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Nivagen Pharmaceuticals, Inc. | 7cb1ecbe-1e7a-4b39-8e1d-0c20f145e177 | 2021-10-29 | Warnings, Adverse reactions | 1731582 1731590 238212 V92SO9WP2I |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.