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NDC 63323-0578-20 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 | 63323-0578 |
|---|---|
| Product ID | 63323-578_779dc924-ecc3-41cc-8cf9-a7354db4f763 |
| Associated GPIs | 49102030002010 49102030002012 49102030002013 49102030002014 |
| GCN Sequence Number | 004886 |
| GCN Sequence Number Description | glycopyrrolate VIAL 0.2 MG/ML INJECTION |
| HIC3 | J2B |
| HIC3 Description | ANTICHOLINERGICS,QUATERNARY AMMONIUM |
| GCN | 19121 |
| HICL Sequence Number | 002028 |
| HICL Sequence Number Description | GLYCOPYRROLATE |
| 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 | ANDA209328 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0578-20 (63323057820)
| NDC Package Code | 63323-578-20 |
|---|---|
| Billing NDC | 63323057820 |
| Package | 10 VIAL, MULTI-DOSE in 1 CARTON (63323-578-20) / 20 mL in 1 VIAL, MULTI-DOSE (63323-578-18) |
| Marketing Start Date | 2017-10-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |