GLYCOPYRROLATE is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Glycopyrrolate.
| Product ID | 52584-396_1b7522d0-24c6-48d3-a4d3-8d8f116a17d4 |
| NDC | 52584-396 |
| Product Type | Human Prescription Drug |
| Proprietary Name | GLYCOPYRROLATE |
| Generic Name | Glycopyrrolate |
| Dosage Form | Injection |
| Route of Administration | INTRAMUSCULAR; INTRAVENOUS |
| Marketing Start Date | 2018-09-17 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA208973 |
| Labeler Name | General Injectables and Vaccines, Inc. |
| Substance Name | GLYCOPYRROLATE |
| Active Ingredient Strength | 1 mg/5mL |
| Pharm Classes | Anticholinergic [EPC],Cholinergic Antagonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2018-09-17 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA208973 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-09-17 |
| Ingredient | Strength |
|---|---|
| GLYCOPYRROLATE | 1 mg/5mL |
| SPL SET ID: | ac0d85b0-9afc-4c3b-854d-3d4856055272 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-1250 | Glycopyrrolate | Glycopyrrolate |
| 0143-1251 | Glycopyrrolate | Glycopyrrolate |
| 0143-9584 | Glycopyrrolate | Glycopyrrolate |
| 0143-9585 | Glycopyrrolate | Glycopyrrolate |
| 0143-9586 | Glycopyrrolate | Glycopyrrolate |
| 0143-9587 | Glycopyrrolate | Glycopyrrolate |
| 0143-9679 | Glycopyrrolate | Glycopyrrolate |
| 0143-9680 | Glycopyrrolate | Glycopyrrolate |
| 0143-9681 | Glycopyrrolate | Glycopyrrolate |
| 0143-9682 | Glycopyrrolate | Glycopyrrolate |
| 0259-0502 | Glycopyrrolate | Glycopyrrolate |
| 0404-9867 | GLYCOPYRROLATE | GLYCOPYRROLATE |
| 0404-9868 | GLYCOPYRROLATE | GLYCOPYRROLATE |
| 0404-9869 | GLYCOPYRROLATE | GLYCOPYRROLATE |
| 0404-9870 | GLYCOPYRROLATE | glycopyrrolate |
| 0517-4601 | Glycopyrrolate | Glycopyrrolate |
| 68001-353 | Glycopyrrolate | Glycopyrrolate |
| 68001-351 | Glycopyrrolate | Glycopyrrolate |
| 68001-352 | Glycopyrrolate | Glycopyrrolate |
| 68001-354 | Glycopyrrolate | Glycopyrrolate |
| 68151-0614 | Glycopyrrolate | Glycopyrrolate |
| 0517-4602 | Glycopyrrolate | Glycopyrrolate |
| 0517-4605 | Glycopyrrolate | Glycopyrrolate |
| 0517-4620 | Glycopyrrolate | Glycopyrrolate |
| 69076-475 | GLYCOPYRROLATE | GLYCOPYRROLATE |
| 69076-476 | GLYCOPYRROLATE | GLYCOPYRROLATE |
| 69067-050 | Glycopyrrolate | Glycopyrrolate |
| 69315-140 | Glycopyrrolate | Glycopyrrolate |
| 69315-139 | Glycopyrrolate | Glycopyrrolate |
| 70069-012 | Glycopyrrolate | Glycopyrrolate |
| 70121-1397 | Glycopyrrolate | Glycopyrrolate |
| 70121-1395 | Glycopyrrolate | Glycopyrrolate |
| 70121-1394 | Glycopyrrolate | Glycopyrrolate |
| 70069-014 | Glycopyrrolate | Glycopyrrolate |
| 70069-011 | Glycopyrrolate | Glycopyrrolate |
| 70069-013 | Glycopyrrolate | Glycopyrrolate |
| 70121-1396 | Glycopyrrolate | Glycopyrrolate |
| 71335-0020 | Glycopyrrolate | Glycopyrrolate |
| 71361-003 | Glycopyrrolate | Glycopyrrolate |
| 71361-002 | Glycopyrrolate | Glycopyrrolate |
| 71361-004 | Glycopyrrolate | Glycopyrrolate |
| 71872-7152 | Glycopyrrolate | Glycopyrrolate |
| 71361-001 | Glycopyrrolate | Glycopyrrolate |
| 71872-7148 | Glycopyrrolate | Glycopyrrolate |
| 71872-7012 | Glycopyrrolate | Glycopyrrolate |
| 71872-7093 | Glycopyrrolate | Glycopyrrolate |
| 71872-7094 | Glycopyrrolate | Glycopyrrolate |
| 76045-203 | Glycopyrrolate | Glycopyrrolate |
| 0615-8170 | Glycopyrrolate | Glycopyrrolate |
| 0641-6034 | Glycopyrrolate | Glycopyrrolate |