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NDC 72485-0101-25 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.
MedlinePlus Drug Summary
Diphenhydramine injection is used to treat allergic reactions, especially for people who are unable to take diphenhydramine by mouth. It is used also to treat motion sickness. Diphenhydramine injection is also used alone or along with other medications to control abnormal movements in people who have Parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Diphenhydramine injection should not be used in newborn or premature infants. Diphenhydramine injection is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 72485-0101-25Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine Injection
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 72485-0101-25 (72485010125)
| NDC Package Code | 72485-101-25 |
|---|---|
| Billing NDC | 72485010125 |
| Package | 25 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01) |
| Marketing Start Date | 2019-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.95497 |
| Pricing Unit | ML |
| Effective Date | 2024-01-17 |
| NDC Description | DIPHENHYDRAMINE 50 MG/ML VIAL |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |