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NDC 76045-0009-11 Dilaudid 1 mg/mL Details
Dilaudid 1 mg/mL
Dilaudid is a INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is HYDROMORPHONE HYDROCHLORIDE.
MedlinePlus Drug Summary
Hydromorphone injection is used to relieve pain. Hydromorphone injection is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Related Packages: 76045-0009-11Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydromorphone Injection
Product Information
| NDC | 76045-0009 |
|---|---|
| Product ID | 76045-009_d2fe0d3b-8eb6-4e54-8418-642f330abbf7 |
| Associated GPIs | 65100035102005 |
| GCN Sequence Number | 062823 |
| GCN Sequence Number Description | hydromorphone HCl/PF SYRINGE 1 MG/ML INJECTION |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 98594 |
| HICL Sequence Number | 034805 |
| HICL Sequence Number Description | HYDROMORPHONE HCL/PF |
| Brand/Generic | Brand |
| Proprietary Name | Dilaudid |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydromorphone hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | NDA |
| Application Number | NDA019034 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 76045-0009-11 (76045000911)
| NDC Package Code | 76045-009-11 |
|---|---|
| Billing NDC | 76045000911 |
| Package | 10 SYRINGE in 1 CARTON (76045-009-11) / 1 mL in 1 SYRINGE (76045-009-01) |
| Marketing Start Date | 2018-12-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |