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NDC 64253-0400-91 Atropine Sulfate 0.1 mg/mL Details
Atropine Sulfate 0.1 mg/mL
Atropine Sulfate is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Medefil, Inc.. The primary component is ATROPINE SULFATE.
Product Information
| NDC | 64253-0400 |
|---|---|
| Product ID | 64253-400_fbfdf718-beff-ad22-e053-6294a90a3715 |
| Associated GPIs | |
| GCN Sequence Number | 004817 |
| GCN Sequence Number Description | atropine sulfate SYRINGE 0.1 MG/ML INJECTION |
| HIC3 | J2A |
| HIC3 Description | BELLADONNA ALKALOIDS |
| GCN | 18661 |
| HICL Sequence Number | 002004 |
| HICL Sequence Number Description | ATROPINE SULFATE |
| Brand/Generic | Generic |
| Proprietary Name | Atropine Sulfate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Atropine Sulfate Injection |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 0.1 |
| Active Ingredient Units | mg/mL |
| Substance Name | ATROPINE SULFATE |
| Labeler Name | Medefil, Inc. |
| Pharmaceutical Class | Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214970 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 64253-0400-91 (64253040091)
| NDC Package Code | 64253-400-91 |
|---|---|
| Billing NDC | 64253040091 |
| Package | 10 SYRINGE, PLASTIC in 1 BOX (64253-400-91) / 10 mL in 1 SYRINGE, PLASTIC (64253-400-30) |
| Marketing Start Date | 2023-05-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |