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NDC 76045-0203-10 Glycopyrrolate 0.2 mg/mL Details
Glycopyrrolate 0.2 mg/mL
Glycopyrrolate is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is GLYCOPYRROLATE.
Product Information
| NDC | 76045-0203 |
|---|---|
| Product ID | 76045-203_d8f5e3e4-34e3-4e52-b76d-69e210e649d5 |
| Associated GPIs | 4910203000E504 4910203000E508 |
| GCN Sequence Number | 079561 |
| GCN Sequence Number Description | glycopyrrolate in water/PF SYRINGE 0.2 MG/ML INJECTION |
| HIC3 | J2B |
| HIC3 Description | ANTICHOLINERGICS,QUATERNARY AMMONIUM |
| GCN | 46075 |
| HICL Sequence Number | 043954 |
| HICL Sequence Number Description | GLYCOPYRROLATE IN STERILE WATER/PF |
| Brand/Generic | Generic |
| Proprietary Name | Glycopyrrolate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Glycopyrrolate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 0.2 |
| Active Ingredient Units | mg/mL |
| Substance Name | GLYCOPYRROLATE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209024 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 76045-0203-10 (76045020310)
| NDC Package Code | 76045-203-10 |
|---|---|
| Billing NDC | 76045020310 |
| Package | 24 BLISTER PACK in 1 CARTON (76045-203-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-203-01) / 1 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2018-07-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |