NDC 63402-681-01 - UTIBRON NEOHALER
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
- 63402-681
- Requested NDC
- 63402-681-01
- Package NDCs from labels
- 63402-681-01, 63402-681-60, 63402-681-06, 63402-681-02, 63402-681-12
- Manufacturer
- Sunovion Pharmaceuticals Inc.
- Effective date
- 2019-05-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| UTIBRON NEOHALER - Sunovion Pharmaceuticals Inc. | Sunovion Pharmaceuticals Inc. | 2019-05-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63402-681-01 | EA - Each | 63402-681 | fdf9a6c3-5389-43b6-b079-50d744dc12f6 | 1 | 2018-04-19 |
| 63402-681-06 | EA - Each | 63402-681 | 9eef7d49-3376-4482-b546-cd4a99897904 | 1 | 2018-04-19 |
| 63402-681-60 | EA - Each | 63402-681 | c91b1e50-982d-4197-8a4c-105b40d16fab | 1 | 2018-06-11 |
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 |
|---|---|---|---|---|---|---|
| BEVESPI AEROSPHERE | GLYCOPYRROLATE AND FORMOTEROL FUMARATE | AstraZeneca Pharmaceuticals LP | ae02436e-9528-490e-a844-0c0f6f2843f9 | 2023-03-24 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Civica, Inc. | 3ac4f32f-f5ca-4a6d-9bc7-2672d478b3d4 | 2023-03-01 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Meitheal Pharmaceuticals Inc. | 02f914a8-2356-4525-91ff-cf0c9e41ba23 | 2023-01-12 | Warnings, Adverse reactions | V92SO9WP2I |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Quinn Pharmaceuticals | e1ded8e0-c05b-4bf4-a129-57d1726af6ed | 2022-12-20 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 26cdd84d-ffa0-4e52-b359-4acef4bd8093 | 2022-11-10 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Camber Pharmaceuticals, Inc. | 4741be85-3abb-4545-aba9-281f64d210ec | 2022-07-13 | Warnings, Adverse reactions | V92SO9WP2I |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Novadoz Pharmaceuticals LLC | 98820c01-1853-45d8-9da5-875fcdf5f9ab | 2022-06-14 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Xiromed LLC | 29618edf-39b0-022a-9875-9d865450d318 | 2022-04-12 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Xiromed, LLC | f777c813-3232-d744-8bcf-58e86fb929bd | 2022-04-12 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Hikma Pharmaceuticals USA Inc. | 516cc4f8-3583-4405-ab66-29d4fcc56d05 | 2022-03-23 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Hikma Pharmaceuticals USA Inc. | d5a18d74-0d40-46e2-aa0a-41d18609a536 | 2022-03-04 | Warnings, Adverse reactions | V92SO9WP2I |
| glycopyrrolate | GLYCOPYRROLATE | BE Pharmaceuticals Inc. | d9df3900-a8c2-438b-8971-ba11ff91f90b | 2022-02-24 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Somerset Therapeutics, LLC | a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6 | 2022-01-27 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | AuroMedics Pharma LLC | eaebb511-1738-4d11-b9bb-317a8d41316a | 2021-12-22 | Warnings, Adverse reactions | V92SO9WP2I |
| GLYCOPYRROLATE | GLYCOPYRROLATE | Nivagen Pharmaceuticals, Inc. | 7cb1ecbe-1e7a-4b39-8e1d-0c20f145e177 | 2021-10-29 | Warnings, Adverse reactions | V92SO9WP2I |
| 10fd07fe-74ed-4bbc-97d4-bfd74a1e7b26 | 7579de3d-caad-4697-b429-760db3e68a23 | 2021-07-30 | Warnings, Adverse reactions | 7579de3d-caad-4697-b429-760db3e68a23 | ||
| GLYCOPYRROLATE | GLYCOPYRROLATE | Alembic Labs LLC | db178372-51d2-4194-bbe2-da9acb1cfd53 | 2020-12-09 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Civica, Inc. | 9f7f1ebf-58e8-4ae7-8157-1595df8ad6f4 | 2020-02-26 | Warnings, Adverse reactions | V92SO9WP2I |
| Glycopyrrolate | GLYCOPYRROLATE | Dr. Reddy's Laboratories Limited | 725529e8-9c4b-4108-690a-e4f391439736 | 2016-11-15 | Warnings, Adverse reactions | V92SO9WP2I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.