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NDC 72485-0101-05 Diphenhydramine Hydrochloride 50 mg/mL Details
Diphenhydramine Hydrochloride 50 mg/mL
Diphenhydramine Hydrochloride is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Armas Pharmaceuticals Inc.. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.
Product Information
| NDC | 72485-0101 |
|---|---|
| Product ID | 72485-101_d949ac61-1864-4cf8-9b51-738b29952cc2 |
| Associated GPIs | 41200030102010 |
| GCN Sequence Number | 011590 |
| GCN Sequence Number Description | diphenhydramine HCl VIAL 50 MG/ML INJECTION |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 46013 |
| HICL Sequence Number | 004480 |
| HICL Sequence Number Description | DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Diphenhydramine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Diphenhydramine Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Armas Pharmaceuticals Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA205723 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 72485-0101-05 (72485010105)
| NDC Package Code | 72485-101-05 |
|---|---|
| Billing NDC | 72485010105 |
| Package | 5 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-05) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01) |
| Marketing Start Date | 2023-05-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |