Search by Drug Name or NDC
NDC 00641-0929-25 Promethazine Hydrochloride 50 mg/mL Details
Promethazine Hydrochloride 50 mg/mL
Promethazine Hydrochloride is a INTRAMUSCULAR INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is PROMETHAZINE HYDROCHLORIDE.
Product Information
| NDC | 00641-0929 |
|---|---|
| Product ID | 0641-0929_5509eac1-ecc4-4054-86cd-3adb966b525c |
| Associated GPIs | 41400020102010 |
| GCN Sequence Number | 003871 |
| GCN Sequence Number Description | promethazine HCl VIAL 50 MG/ML INJECTION |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 14983 |
| 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 |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Phenothiazine [EPC], Phenothiazines [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA083312 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00641-0929-25 (00641092925)
| NDC Package Code | 0641-0929-25 |
|---|---|
| Billing NDC | 00641092925 |
| Package | 25 VIAL, SINGLE-DOSE in 1 PACKAGE (0641-0929-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0641-0929-21) |
| Marketing Start Date | 1973-09-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |