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NDC 00641-0376-25 Diphenhydramine Hydrochloride 50 mg/mL Details
Diphenhydramine Hydrochloride 50 mg/mL
Diphenhydramine Hydrochloride is a INTRAMUSCULAR; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine 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: 00641-0376-25Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
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: 00641-0376-25Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine Injection
Product Information
| NDC | 00641-0376 |
|---|---|
| Product ID | 0641-0376_bb796e58-4ee5-4fa7-9e48-6cb8bd7856f4 |
| 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 |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA080817 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00641-0376-25 (00641037625)
| NDC Package Code | 0641-0376-25 |
|---|---|
| Billing NDC | 00641037625 |
| Package | 25 VIAL in 1 PACKAGE (0641-0376-25) / 1 mL in 1 VIAL (0641-0376-21) |
| Marketing Start Date | 1972-11-27 |
| 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 |