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NDC 68382-0860-10 Benztropine Mesylate 1 mg/mL Details
Benztropine Mesylate 1 mg/mL
Benztropine Mesylate is a INTRAMUSCULAR; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is BENZTROPINE MESYLATE.
Product Information
| NDC | 68382-0860 |
|---|---|
| Product ID | 68382-860_ae4dfaeb-246c-4530-b473-656cce5da837 |
| Associated GPIs | 73100010102005 |
| GCN Sequence Number | 065420 |
| GCN Sequence Number Description | benztropine mesylate VIAL 2 MG/2 ML INJECTION |
| HIC3 | H6B |
| HIC3 Description | ANTIPARKINSONISM DRUGS,ANTICHOLINERGIC |
| GCN | 27379 |
| HICL Sequence Number | 001905 |
| HICL Sequence Number Description | BENZTROPINE MESYLATE |
| Brand/Generic | Generic |
| Proprietary Name | Benztropine Mesylate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benztropine Mesylate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | BENZTROPINE MESYLATE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091525 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0860-10 (68382086010)
| NDC Package Code | 68382-860-10 |
|---|---|
| Billing NDC | 68382086010 |
| Package | 5 VIAL in 1 CARTON (68382-860-10) / 2 mL in 1 VIAL (68382-860-02) |
| Marketing Start Date | 2020-12-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |