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NDC 39822-5550-06 PROMETHAZINE HYDROCHLORIDE 50 mg/mL Details
PROMETHAZINE HYDROCHLORIDE 50 mg/mL
PROMETHAZINE HYDROCHLORIDE is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by XGen Pharmaceuticals DJB, Inc.. The primary component is PROMETHAZINE HYDROCHLORIDE.
Product Information
| NDC | 39822-5550 |
|---|---|
| Product ID | 39822-5550_0e860109-725f-1c28-e063-6394a90a50ef |
| Associated GPIs | 41400020102010 |
| GCN Sequence Number | 003867 |
| GCN Sequence Number Description | promethazine HCl AMPUL 50 MG/ML INJECTION |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 14971 |
| HICL Sequence Number | 012014 |
| HICL Sequence Number Description | PROMETHAZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | PROMETHAZINE HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | PROMETHAZINE HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Labeler Name | XGen Pharmaceuticals DJB, Inc. |
| Pharmaceutical Class | Phenothiazine [EPC], Phenothiazines [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA040737 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 39822-5550-06 (39822555006)
| NDC Package Code | 39822-5550-6 |
|---|---|
| Billing NDC | 39822555006 |
| Package | 25 AMPULE in 1 CARTON (39822-5550-6) / 1 mL in 1 AMPULE (39822-5550-5) |
| Marketing Start Date | 2015-01-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |